Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments
Phase: NA
Conditions: Urinary Retention
Sponsor: SRS Medical

CONFIDENTIAL
Use of The Spanner® Temporary Prostatic Stent as an 
Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments 
CIP Reference Number SRS 1.0 
          Rev D
January 27, 2016 
Sponsor: 
SRS Medical Systems, Inc. 
76 Treble Cove Road, Building 3 
North Billerica, MA  01862 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 2 of 76 
Table of Contents 
 
1 
Identification of the Clinical Investigation Plan ................................................................ 6 
1.1 
Title ....................................................................................................................................6 
1.2 
Reference Number ..............................................................................................................6 
1.3 
Version Number ..................................................................................................................6 
1.4 
Revision History ..................................................................................................................6 
2 
Sponsor .......................................................................................................................... 6 
2.1 
Sponsor Contact Information ...............................................................................................6 
2.2 
Responsibilities for Ethical Conduct .....................................................................................6 
2.3 
Nondisclosure Statement - Restricted Distribution of Documents .........................................7 
3 
Investigators and Institutional Review Boards ................................................................ 8 
3.1 
Investigator’s Statement and Signature ...............................................................................8 
4 
Study Synopsis ................................................................................................................ 9 
5 
The Investigational Device ............................................................................................ 10 
5.1 
Intended Purpose .............................................................................................................. 10 
5.2 
Proposed Expanded Indications For Use ............................................................................. 10 
5.3 
Device Description ............................................................................................................ 10 
5.4 
Stent Configuration ........................................................................................................... 11 
5.5 
The Spanner Insertion Tool ................................................................................................ 13 
5.6 
Surveyor ........................................................................................................................... 14 
5.7 
Manufacturers .................................................................................................................. 16 
5.8 
Model Matrices ................................................................................................................. 16 
5.9 
Traceability ....................................................................................................................... 17 
5.10 
Intended Purpose and Population ...................................................................................... 17 
5.11 
Materials Contacting Tissues or Body Fluids ....................................................................... 17 
5.12 
Urologist Experience and Training Requirements ............................................................... 17 
5.13 
Procedures ........................................................................................................................ 17 
6 
Justification for the Clinical Investigation ...................................................................... 20 
6.1 
Study Background and Justification.................................................................................... 20 
6.2 
Relevant Pre-clinical Testing .............................................................................................. 20 
6.3 
Prior Clinical Studies .......................................................................................................... 20 
7 
Risks and Benefits of the Investigational Device and Clinical Investigation .................... 20 
7.1 
Anticipated Clinical Benefits .............................................................................................. 20 
7.2 
Anticipated Adverse Device Effects .................................................................................... 21 
7.3 
Anticipated Device Deficiencies ......................................................................................... 21 
7.4 
Risks Associated With Participation in the Clinical Investigation ......................................... 22 
7.5 
Possible Interactions with Concomitant Medical Treatments .............................................. 22 
7.6 
Residual Risks ................................................................................................................... 22 
7.7 
Mitigation of Risks ............................................................................................................ 22 
7.8 
Risk-to-Benefit Rationale ................................................................................................... 23 
8 
Objectives and Hypotheses of the Clinical Investigation ................................................ 23 
8.1 
Primary Objective.............................................................................................................. 23 
8.2 
Secondary Objectives ........................................................................................................ 23 
8.3 
Study Hypotheses ............................................................................................................. 24 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 3 of 76 
8.4 
Adverse Events .................................................................................................................. 24 
9 
Design of the Clinical Investigation ............................................................................... 24 
9.1 
Measures to Avoid Bias ..................................................................................................... 25 
9.2 
Primary and Secondary Endpoints ..................................................................................... 25 
9.3 
Methods and Timing for Assessing, Recording, and Analyzing Variables .............................. 25 
9.4 
Randomization .................................................................................................................. 26 
9.5 
Pooling of Study Centers.................................................................................................... 26 
9.6 
Equipment Maintenance and Calibration ........................................................................... 26 
9.7 
Procedures for Replacement of Subjects ............................................................................ 26 
10 Exposure to Investigational Devices and Medications .................................................... 26 
10.1 
Exposure to the Investigational Device............................................................................... 26 
10.2 
Recommended Medications .............................................................................................. 26 
10.3 
Number of Investigational Devices Needed ........................................................................ 27 
11 Subjects ........................................................................................................................ 27 
11.1 
Inclusion Criteria ............................................................................................................... 27 
11.2 
Exclusion Criteria ............................................................................................................... 27 
11.3 
Subject Withdrawal or Discontinuation .............................................................................. 28 
11.4 
Point of Enrollment ........................................................................................................... 28 
11.5 
Expected Individual Subject Participation and Total Duration of the Clinical 
Investigation ................................................................................................................................ 29 
11.6 
Number of Subjects Required ............................................................................................ 30 
12 Procedures ................................................................................................................... 30 
12.1 
Study Activities Table ........................................................................................................ 30 
12.2 
Foreseeable Factors that May Compromise the Outcome of the Clinical Investigation ......... 34 
13 Monitoring Plan ........................................................................................................... 35 
13.1 
Monitor Name and Address ............................................................................................... 35 
13.2 
Monitor Responsibilities .................................................................................................... 35 
13.3 
Procedures ........................................................................................................................ 35 
13.4 
Monitoring and Audit Visits ............................................................................................... 36 
14 Statistical Considerations .............................................................................................. 38 
14.1 
Level of Significance, Power and Sample Size ..................................................................... 39 
14.2 
Expected Drop-out Rates ................................................................................................... 39 
14.3 
Primary Effectiveness Variable and Pass/Fail Criteria ......................................................... 39 
14.4 
Secondary Effectiveness Variable ....................................................................................... 39 
14.5 
Exploratory Effectiveness Variable ..................................................................................... 39 
14.6 
Safety Variables ................................................................................................................ 39 
14.7 
Analysis of the Secondary Effectiveness Variables .............................................................. 41 
14.8 
Analysis of Safety Variables ............................................................................................... 41 
14.9 
Specification of subgroups for analysis ............................................................................... 41 
14.10 
Reporting Deviations from the SAP ................................................................................ 41 
14.11 
Treatment of Missing Data, Including Lost to Follow-up and Withdrawals ....................... 41 
14.12 
The Number of Subjects at Each Center .......................................................................... 41 
15 Data Management ....................................................................................................... 41 
15.1 
Electronic Case Report Form Completion ........................................................................... 41 
15.2 
Data Confidentiality .......................................................................................................... 42 
15.3 
Access to Data ................................................................................................................... 42 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 4 of 76 
15.4 
Data Review, Database Cleaning and Queries .................................................................... 43 
15.5 
Database Development ..................................................................................................... 43 
15.6 
Database Validation .......................................................................................................... 44 
15.7 
Record Retention Period ................................................................................................... 44 
16 Amendments to the CIP ................................................................................................ 44 
17 Deviations from the CIP ................................................................................................ 44 
17.1 
Notification Requirements................................................................................................. 45 
17.2 
Corrective and Preventive Actions and Principal Investigator Disqualification Criteria ......... 45 
17.3 
Procedure for Analyzing CIP Deviations .............................................................................. 45 
18 Investigational Device Documentation and Shipping ..................................................... 46 
18.1 
Labeling ............................................................................................................................ 46 
19 Statements of Compliance ............................................................................................ 46 
19.1 
Statements of Compliance ................................................................................................. 46 
19.2 
Insurance .......................................................................................................................... 46 
20 Informed Consent Process ............................................................................................. 46 
21 Adverse Events, Adverse Device Effects and Device Deficiencies .................................... 47 
21.1 
Definitions ........................................................................................................................ 47 
21.2 
AE Assessment, Documentation and Reporting .................................................................. 49 
21.3 
Reporting Device Deficiencies. ........................................................................................... 49 
21.4 
Foreseeable Device Deficiencies/Malfunctions ................................................................... 49 
21.5 
Managing Adverse Events and Device Deficiencies ............................................................. 49 
21.6 
Emergency Sponsor Contact Information for Reporting SAE and SADE ................................ 53 
21.7 
Data Monitoring Committee, ............................................................................................. 53 
22 Vulnerable Population .................................................................................................. 53 
23 Suspension or Premature Termination of the Clinical Investigation ................................ 53 
23.1 
Procedure for Suspension or Premature Termination ......................................................... 53 
23.2 
Procedure for Resuming the Clinical Investigation After Temporary Suspension .................. 54 
24 Publication Policy ......................................................................................................... 54 
24.1 
Confidentiality Agreement ................................................................................................ 54 
24.2 
Subject Confidentiality ...................................................................................................... 55 
24.3 
Ownership of Data and Use of Study Results ...................................................................... 55 
24.4 
Publication Policy .............................................................................................................. 55 
24.5 
Clinical Trial Registration ................................................................................................... 55 
25 Instititional Review Board (IRB) .................................................................................... 55 
25.1 
IRB Approval ..................................................................................................................... 55 
25.2 
Continuing Communication with the IRB ............................................................................ 56 
26 INVESTIGATOR RESPONSIBILITIES ................................................................................. 56 
26.1 
Qualification of the Principal Investigator .......................................................................... 56 
26.2 
Qualification of investigation site ...................................................................................... 57 
26.3 
Study Agreement .............................................................................................................. 57 
26.4 
Communication with the IRB ............................................................................................. 57 
26.5 
Informed Consent Process ................................................................................................. 57 
26.6 
Compliance with the CIP .................................................................................................... 57 
26.7 
Medical Care of Subjects ................................................................................................... 59 
26.8 
Safety Reporting ............................................................................................................... 59 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 5 of 76 
27 RESPONSIBILITIES OF THE SPONSOR .............................................................................. 60 
27.1 
Clinical Quality Assurance and Quality Control ................................................................... 60 
27.2 
Clinical Investigation Planning and Conduct ....................................................................... 60 
27.3 
Preparation of Documents and Materials ........................................................................... 61 
27.4 
Conduct of the Clinical Investigation .................................................................................. 61 
27.5 
Monitoring ........................................................................................................................ 62 
27.6 
Safety Evaluation and Reporting ........................................................................................ 64 
27.7 
Outsourcing of Duties and Functions .................................................................................. 65 
27.8 
Communication With Regulatory Authorities ..................................................................... 66 
28 Bibliography ................................................................................................................. 67 
Attachment A:  Device Labeling ........................................................................................... 68 
Attachment B:  Spanner Study Procedure For Uroflow Testing.............................................. 69 
Attachment C:  Charlson Weighted Index of Comorbidity ..................................................... 71 
Attachment D:  Study Subject Materials ............................................................................... 72 
Attachment E:  Electronic Case Report Forms ....................................................................... 73 
Attachment F:  Materials in Contact With Tissues or Body Fluids .......................................... 74 
Attachment G:  Abbbreviations ............................................................................................ 76 
 
Table of Tables 
Table 1.  CIP Revision History  
Table 2.  Contact Information for Investigators 
Table 3.  Spanner Sizes 
Table 4.  Surveyor Device  
Table 5.  Study Activities 
 
Table of Figures 
Figure 1:  Spanner Stent (positioned in the prostatic urethra) 
Figure 2:  Spanner Stent 
Figure 3: Spanner Stent with Distal Curve 
Figure 4:  Insertion Tool 
Figure 5: Surveyor Device 
Figure 6:  Surveyor (positioned in prostatic urethra) & Spanner Selector Card 
Figure 7.  Inserting the Spanner 
Figure 8.  Removing the Spanner 
Figure 9. Flowchart of Subject Screening, Enrollment and Spanner Insertion 
 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 6 of 76 
1 IDENTIFICATION OF THE CLINICAL INVESTIGATION PLAN 
1.1 
Title 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter 
to Achieve Bladder Drainage in Men Unfit for Other Treatments 
1.2 
Reference Number 
 
CIP Reference Number SRS 1.0 
1.3 
Version Number 
 
Rev. A, November 13, 2015 
1.4 
Revision History 
 
Table 1.  CIP Revision History 
Revision 
Revision Date 
Summary of Changes 
A 
Nov 13 2015 
Original IDE Submission 
B 
Dec 14 2015 
Updates per FDA Request on Dec 11 2015 
C 
Dec 15 2015 
Updates per FDA Request on Dec 15 2015 
D 
Jan 27 2016 
Updates per IDE Approval Letter 
Recommendations of Dec 16 2015 
2 SPONSOR 
2.1 
Sponsor Contact Information 
The sponsor of this study is:  
SRS Medical Systems, Inc. 
76 Treble Cove Road, Building 3 
North Billerica, MA  01862 
The sponsor will maintain a study contact list and updates will be provided to the sites 
and available upon request.  
For inquiries and further information about the study or for reporting of serious adverse 
events and other emergencies, contact: 
Lee Brody. 
CEO 
SRS Medical  
(978) 932-0400 
(617) 308-4056 [24 hours] 
brody@srsmedical.com 
2.2 
Responsibilities for Ethical Conduct 
All parties involved in the conduct of the clinical investigation shall share responsibility 
for its ethical conduct in accordance with their respective roles in the investigation and 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 7 of 76 
shall be appropriately qualified by education or experience to perform their tasks and this 
shall be documented appropriately.   
The sponsor shall avoid improper influence on, or inducement of, the subject, monitor, 
any investigators or other parties participating in, or contributing to the clinical 
investigation.  All investigators shall avoid improper influence on, or inducement of, the 
subject, monitor, the sponsor or other parties participating in, or contributing to the 
clinical investigation.   
2.3 
Nondisclosure Statement - Restricted Distribution of Documents 
This document contains information that is confidential and proprietary to the sponsor. 
This information is being provided solely for the purpose of evaluating and/or conducting 
a clinical trial for the sponsor. You may disclose the contents of this document only to 
study personnel under your supervision, IRB, or duly authorized representatives of 
regulatory agencies for this purpose under the condition that they maintain 
confidentiality. The contents of this document may not be used in any other clinical trial, 
disclosed to any other person or entity, and/or published without the prior written 
permission of the sponsor. The foregoing shall not apply to disclosure required by any 
regulations; however, you will give prompt notice to the sponsor of any such disclosure. 
Any information that may be added to this document also is confidential and proprietary 
to the sponsor and must be kept in confidence in the same manner as the contents of 
this document.  

SRS Medical Systems, Inc. 
CONFIDENTIAL 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 8 of 76 
3  INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS 
Table 2 lists investigator candidates for this study.  The IRBs will be determined on a 
site by site basis and will be local institutional or an independent contract institutional 
review boards. Contact information will be updated throughout the course of the study. 
The updated contact list will be kept at SRS Medical and is available upon request. 
Table 2.  Contact Information for Investigators 
 
 
 
 
 
3.1 
Investigator’s Statement and Signature 
I have read this clinical investigation plan (CIP) and agree that it contains all necessary 
details for carrying out the study as described. I will conduct this CIP as outlined herein, 
including all statements regarding confidentiality. I will make a reasonable effort to 
complete the study within the time discussed. I will provide copies of the CIP and access 
to all information furnished by the sponsor to study personnel under my supervision. I 
will discuss this material with them to ensure that they are fully informed about the 
investigational device and the study. I understand that the study may be terminated or 
enrollment suspended at any time by the sponsor, with or without cause, or by me if it 
becomes necessary to protect the best interests of the study subjects. I agree to conduct 
this study in full accordance with this protocol, all applicable regulations, the Declaration 
of Helsinki and Good Clinical Practices (GCP). 
______________________________ 
______________ 
___________ 
Principal Investigator’s Signature 
Date    
Site # 

SRS Medical Systems, Inc. 
CONFIDENTIAL 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 9 of 76 
4 STUDY SYNOPSIS 
Study Title 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter 
to Achieve Bladder Drainage in Men Unfit for Other Treatments 
Study Number 
SRS 1.0 
Purpose 
To expand the indications for use by evaluating the safety and efficacy of The Spanner 
to manage voiding dysfunction and lower urinary tract symptoms in subjects who are 
not candidates for pharmacologic, minimally invasive or surgical treatment of the 
prostate.   
Device 
The Spanner® Temporary Prostatic Stent 
Current 
Indications for 
Use 
The Spanner is intended for temporary use (up to 30 days) to maintain urine flow and allow 
voluntary urination in subjects following minimally invasive treatment for benign prostatic 
hyperplasia (BPH) and after initial post-treatment catheterization. 
Proposed 
Indications for 
Use 
The Spanner Temporary Prostatic Stent is intended for temporary use (up to 30 days) to 
maintain urine flow and allow voluntary urination for subjects who are not candidates for 
pharmacologic, minimally invasive or surgical treatment of the prostate. 
Design 
The proposed investigation is a prospective, multicenter, single-arm, open-label trial.  
Enrolling approximately 105 subjects who are dependent on a urinary catheter. Subjects will 
be fitted with a Spanner stent and the stent will be replaced at an interval of approximately 30 
days for a total of up to 90 days of use.  Subjects will complete the study upon removal of the 
Spanner stent after 90 days and one follow-up telephone call post-removal. PVR, uroflow, 
urinary symptoms, subject satisfaction and the occurrence of adverse events will be collected. 
Cystoscopy will be performed prior to the initial stent placement and after the final stent 
removal to determine any effects of The Spanner on lower urinary tract anatomy. 
Primary 
Objectives 

To determine the proportion of subjects who achieve adequate bladder drainage over 90
days, defined as a post-void residual (PVR) of ≤150 ml.

The pre-specified success criterion for this study is that ≥50 percent of subjects will
achieve adequate bladder drainage over 90 days.
Secondary 
Objectives 

To measure the effects of the Spanner stent on bladder drainage, defined by the
proportion of subjects who achieve a post-void residual of:
o ≤150 ml over 30 days.
o ≤250 ml over 30 days.
o ≤250 ml over 90 days.

To measure the effects on maximum flow rate as assessed by Uroflow

To measure the effects on the International Prostate Symptom Score
Key Inclusion 
Criteria 

Age > 45 years;

Subject in urinary retention and catheterized (indwelling or intermittent) < 180 days;

Subject has a documented diagnostic history of detrusor contractility (>= 15 cmH2O) ,

Subject has a negative Urinalysis on Visit 1;

Subject not a candidate for pharmacologic, minimally invasive or surgical prostate
treatments;

Subject is experiencing catheter-induced discomfort

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 10 of 76 
Key Exclusion 
Criteria 
 
Current or recent urinary tract disease; 
 
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect 
the function of the lower urinary tract; 
 
History of conditions associated with neurogenic bladder, including spinal cord injury, 
multiple sclerosis, or Parkinson’s disease; 
 
Use of anticholinergic medication; 
 
Known or suspected prostate cancer; 
 
Prior pelvic irradiation therapy; 
 
Prostatic urethral length < 4 cm or > 9 cm  
 
Intravesical enlargement of the median lobe of the prostate. 
 
Prior penile prosthesis 
5 THE INVESTIGATIONAL DEVICE 
5.1 
Intended Purpose 
The Spanner is intended for temporary use (up to 30 days) to maintain urine flow and 
allow voluntary urination in subjects following minimally invasive treatment for benign 
prostatic hyperplasia (BPH) and after initial post-treatment catheterization. 
5.2 
Proposed Expanded Indications For Use 
The Spanner Temporary Prostatic Stent is intended for temporary use (up to 30 days) to 
maintain urine flow and allow voluntary urination for subjects who are not candidates for 
pharmacologic, minimally invasive or surgical treatment of the prostate. 
5.3 
Device Description 
The Spanner temporary prostatic stent is a sterile, single use, disposable intraurethral 
device.  The Spanner is available in 20F diameter, 6 sizes (lengths 4, 5, 6, 7, 8, and 9 
cm).  The Spanner stent is positioned in the prostatic urethra from the bladder neck to 
the top (proximal side) of the external urinary sphincter (see Figure 1).  The stent portion 
(A) of the Spanner is made of silicone.  The stent is held in position by a silicone balloon 
(B) and in the bulbar urethra by a soft, silicone, distal anchor (C). A stainless steel wire-
form is encapsulated into the body of the distal anchor to maintain its shape. The distal 
anchor is attached to the stent by means of a silicone coated device suture (D). The 
length of the connecting suture is such that it traverses the external sphincter, 
positioning the anchor on the bottom (distal side) of the sphincter to prevent migration 
inward to the bladder, while allowing normal sphincter function to occur. A retrieval 
suture (E) is attached to the device suture below the distal anchor.  A stainless steel 
balloon plug, which is inserted into the balloons deflation port, is located at the end of the 
retrieval suture.  The retrieval suture is provided in sufficient length to extend through the 
urethra, exterior of the penis.  To remove the device, gentle traction is applied to the 
retrieval suture to remove the balloon plug and deflate the balloon. After pausing a few 
seconds to allow balloon deflation, the device is withdrawn by slowly pulling on the 
retrieval suture.  To facilitate device insertion and balloon inflation, the Spanner stent is 
mounted on an Insertion Tool.  The Spanner stent system also includes an accessory, 
the Surveyor®, which is used for proper Spanner size selection.  A detailed description of 
the Spanner stent, Insertion Tool, and Surveyor device configurations is provided below. 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 11 of 76 
Figure 1:  Spanner Stent (positioned in the prostatic urethra) 
 
 
 
 
5.4 
Stent Configuration 
The Spanner, shown in Figure 2 comprises a stent portion, proximal balloon anchor, 
device sutures, and a distal anchor.  The stent is provided in a range of lengths.  The 
combined length of the actual stent portion (A) and the device suture portion (D) 
determine the device size, which are 4, 5, 6, 7, 8 & 9 centimeters in length respectively.  
The balloon (B) and distal anchor (C) are identical on all device sizes.  
The stent portion (A) is made of silicone.  The stent is held in position by a silicone 
balloon on its proximal end (B) and a soft, silicone, distal anchor (C) on the distal end.  
Silicone-coated device sutures (D) attach the distal anchor to the stent.  A retrieval 
suture (E) is attached to the device sutures. The retrieval suture is designed to extend 
through the urethra and the urethral meatus.  
 
 
  B – Silicone Balloon 
C – Dist. Anchor 
D – Device Suture 
E – Retrieval Suture 
  A – Stent 
Bottom (distal) 
Top 
(proximal) 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 12 of 76 
Figure 2:  Spanner Stent 
(Figure is not to scale) 
 
 
 
 
B – Silicone 
Balloon 
E – Retrieval 
Suture 
D – Device 
Sutures 
C – Distal Anchor 
A – Stent Portion 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 13 of 76 
 
Spanner sizes 6, 7, 8, and 9 include a distal curve to the stent to align with the prostatic 
urethral anatomy (Figure 3). 
Figure 3: Spanner Stent with Distal Curve 
(Figure is not to scale) 
 
 
 
5.5 
The Spanner Insertion Tool 
To facilitate device insertion and balloon inflation, the Spanner stent is mounted on a 
sterile, single use Insertion Tool, shown in Figure 4.  A polyurethane inflation tube (A) 
extends the length of the Insertion Tool. A silicone sheath (B) surrounds the inflation 
tube. The sheath is reinforced with a stainless steel coil and attached to the hand piece 
(C). The proximal end of the sheath, the distal anchor sleeve (D), houses the Spanner 
stent distal anchor until it is deployed.  The push cup (E) is used for anchor deployment.  
The spacer sleeve (F) provides a smooth transition between the stent and distal anchor 
when loaded on the Insertion Tool.  The inflation tube lumen extends from an inflation 
port (G) on the distal end to a side hole (H) located on the proximal end.  The side hole 
is bounded by two seal rings (I). 
The hand piece of the Insertion Tool includes a coudé tip orientation mark (J).  The 
coudé tip orientation mark is used as a reference during insertion.  The Spanner is 
inserted with coudé tip directed to the subject’s anterior. 
 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 14 of 76 
 
 
Figure 4:  Insertion Tool 
 
 
 
 
 
 
 
 
 
(Figure not to scale) 
 
5.6 
Surveyor 
The Spanner stent system also includes an accessory that is provided separately, the 
Surveyor®.  The Surveyor, shown in Figure 5, is a sterile, single use device used to 
assess the length of the urethra from the top (proximal side) of the bladder neck to the 
bottom (distal side) of the external sphincter in order to select the appropriate Spanner 
stent size. The Surveyor has a coudé-tip. The Surveyor consists of a polyurethane 
inflation tube (A) with a silicone balloon (B) on the proximal end and a hand piece 
assembly (C) on the distal end. The Surveyor lumen, which extends from an inflation 
port stopcock on the hand piece assembly to the balloon, is used to inject fluid to inflate 
the balloon. A short PTFE1 probe tip (D) (approximately 1 cm length) encircles the 
inflation tube and is able to slide freely along the tube length between the balloon and 
the stop. A stainless steel probe wire (E) is attached to the probe tip and extends along 
the length of the Surveyor and through the stop (F) and wire guide (G), where it is 
attached to a probe wire handle (H).  The gap (I) between the probe wire handle and 
wire guide indicates the length from the bladder neck to the distal side of the external 
sphincter; this length, in conjunction with the Spanner Selector card, is used to select the 
appropriate size Spanner. 
 
 
 
 
                                               
1 PTFE:  Polytetrafluoroethylene a.k.a. Teflon® 
 
A – Inflation 
Tube 
B – Silicone 
Sheath 
D – Distal 
Anchor Sleeve 
G – Inflation 
Port 
H –  
Side Hole
  C – Hand Piece 
I – Seal Rings      
 E – Push Cup 
F – Spacer Sleeve 
 J – Orientation Mark 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 15 of 76 
Figure 5: Surveyor Device 
 
 
 
 
 
 
 
 
B - Silicone Balloon 
E – Probe Wire 
H – Probe Wire Handle 
I – Distance used to 
determine appropriate 
Spanner size 
C – Hand Piece 
F - Stop 
A – Inflation Tube 
D – Probe Tip 
G – Wire Guide 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 16 of 76 
5.7 
Manufacturers 
Manufacturer: 
SRS Medical Systems, Inc.  
76 Treble Cove Road, Building 3 
North Billerica, MA  01862 
FDA Establishment Registration Number: 1223851 
 
Contract Manufacturer:  
ProMed Pharma LLC 
15600 Medina Road 
Suite 100 
Minneapolis, MN 55447 
FDA Establishment Registration Number: 3003335547 
  
Contract manufacturer ProMed Pharma LLC (ProMed) is the sole manufacture of The 
Spanner and Surveyor (accessory).  The ProMed cleanroom meets ISO 14644:1999 
class 7 cleanroom requirements and is The Spanner and Surveyor manufacturing facility 
and manufacturing documentation is annually inspected by FDA. 
5.8 
Model Matrices 
The Spanner stent is provided in one diameter (20 Fr) in lengths ranging from 4 to 9 cm, 
in 1 cm increments.  Table 3 identifies the part, catalog and device identifier numbers for 
each Spanner stent size.  Surveyor information is provided in Table 4. 
 
Table 3.  Spanner Sizes 
Description 
Diameter 
(F) 
Size/ 
Length 
(cm) 
Device Part 
Numbers 
Catalog 
Number 
Device Identifier  
Number 
Spanner 
with 
Insertion 
Tool/High 
Flex Stent 
20 
4 
2009004-4HA 
SPNR-
4HA 
00890477000005 
5 
2009004-5HA 
SPNR-
5HA 
00890477000012 
6 
2009004-6HA 
SPNR-
6HA 
00890477000029 
7 
2009004-7HA 
SPNR-
7HA 
00890477000036 
8 
2009004-8HA 
SPNR-
8HA 
00890477000043 
9 
2009004-9HA 
SPNR-
9HA 
00890477000050 
 

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Table 4.  Surveyor Device 
Description 
Tip 
configuration 
Device  
Part Number 
Catalog Number 
Device Identifier  
Number 
Surveyor 
Urethral 
Measurement 
Device 
Coudé 
2007900-02 
SURV-02 
00890477000067 
 
5.9 
Traceability  
Device traceability will be accomplished by device Lot Number. 
5.10 Intended Purpose and Population  
The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary 
tract symptoms in subjects who are not candidates for pharmacologic, minimally invasive 
or surgical treatment of the prostate.   
The Spanner Temporary Prostatic Stent is intended for temporary use (up to 30 days) to 
maintain urine flow and allow voluntary urination for subjects who are not candidates for 
pharmacologic, minimally invasive or surgical treatment of the prostate. 
5.11 Materials Contacting Tissues or Body Fluids 
All materials used to construct The Spanner stent, Insertion Tool, and Surveyor are 
commonly used in commercially available urological devices and are shown in 
Attachment F. 
5.12 Urologist Experience and Training Requirements 
Urologists and their staff participating in the clinical study will receive device training by 
Sponsor personnel on use of The Spanner and Surveyor prior to use in this clinical 
investigation.   
5.13 Procedures 
The appropriate Spanner size for the subject is determined using the Surveyor 
accessory device.  The Surveyor (see Figure 6) is a tool used to assess the distance 
from the top (proximal side) of the bladder neck (A) to the bottom (distal side) of the 
external sphincter (B).  This distance corresponds to the distance from the Spanner 
balloon to the distal anchor when the Spanner resides in situ.  The Surveyor is 
introduced into the urethra and slowly advanced into the bladder.  After entering the 
bladder a balloon located near the end of the Surveyor is inflated with 5cc sterile water.  
Gentle traction seats the Surveyor balloon on top of the bladder neck.  A small probe 
(similar to a piston with its own “push rod”) slides along the Surveyor inflation tube 
through the length of the pendulous urethra to the level of the bottom (distal side) of the 
external sphincter.  Components of the Surveyor, external of the subject, replicate the 
position of the probe relative to the bottom of the external sphincter.  The Spanner 
Selector Card is then used in conjunction with the Surveyor to select the appropriate 

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Spanner size.  The Surveyor balloon is subsequently deflated and the device is 
withdrawn. 
 
Figure 6:  Surveyor (positioned in prostatic urethra) & Spanner Selector 
Card 
 
A – Top of Bladder 
B – Bottom of External 
Sphincter 

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The selected Spanner is mounted on the Insertion Tool (provided in the Spanner 
package) and coated with a water soluble lubricant.  The stent is then inserted into the 
urethral meatus, and utilizing tactile feedback, advanced along the pendulous urethra 
until the proximal tip and proximal balloon of the Spanner are positioned well within the 
bladder (Figure 7).  The balloon is inflated with 5cc of sterile water.  Continuous gentle 
traction is applied on the Insertion Tool to seat the Spanner balloon on top of the bladder 
neck and deploy the anchoring device distal to the external sphincter in the bulbar 
urethra.  Once the balloon is seated and the anchoring device deployed, the Insertion 
Tool is withdrawn from the urethra.   
 
Figure 7.  Inserting the Spanner 
 
 
Only the device sutures pass through the sphincter area allowing the man’s external 
sphincter to function normally, controlling urination and continence.  The stent is held in 
place using the proximal balloon in the bladder neck to prevent expulsion and the distal 
anchor, distal of the external sphincter, to prevent migration. 
The Spanner may be worn for up to 30 days, after which it is removed by simply pulling 
the retrieval suture to first deflate the balloon and then subsequently withdraw the device 
(Figure 8).   
Detailed procedures for using the Spanner stent, Insertion Tool, and Surveyor are 
provided in the Instructions for Use (see Attachment A). 
 
Figure 8.  Removing the Spanner 
 

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6 JUSTIFICATION FOR THE CLINICAL INVESTIGATION 
6.1 
Study Background and Justification 
This investigational plan describes a proposed clinical trial for The Spanner® Temporary 
Prostatic Stent.  The Spanner is designed to provide a temporary means to relieve 
obstruction of the bladder outlet while maintaining volitional voiding ability. 
The Spanner is a PMA Approved Device (PMA 060010) and has been on the US market 
continuously since December 2006.  The Spanner is approved for temporary use (up to 
30 days) to maintain urine flow and allow voluntary urination in subjects following 
minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-
treatment catheterization. This clinical trial is intended to provide additional clinical data 
to support an expanded indication to a particularly needy subject population. 
In the proposed investigation, The Spanner is being evaluated for use to manage voiding 
dysfunction and lower urinary tract symptoms in subjects who are not candidates for 
pharmacologic, minimally invasive or surgical treatment of the prostate.  These subjects 
often have no alternative to relieve urinary retention other than a urinary catheter.  
Urinary catheters passively drain the bladder by placing a tube into the bladder that 
extends past the meatus and draining the urine into an external drainage bag or toilet.  
The proposed investigation evaluates the safety and effectiveness of using The Spanner 
as an alternative to a urinary catheter for these subjects.  The Spanner is a completely 
internal stent that provides a means for these subjects to achieve normal micturition and 
avoid the known and serious complications that occur due to the urinary catheter’s 
external components. The fully internal design of The Spanner also has been shown to 
improve subject quality of life.  
6.2 
Relevant Pre-clinical Testing 
The Spanner is a PMA Approved Device (PMA 060010) and has been on the US market 
continuously since December 2006.  Non-clinical device testing performed includes 
biocompatibility/toxicology, sterilization, shelf life/distribution, and design verification. 
6.3 
Prior Clinical Studies 
The safety and effectiveness of The Spanner was evaluated in a prospective, 
randomized, multi-center clinical investigation (IDE G020140).  This clinical trial is 
intended to provide additional clinical data to support an expanded indication to a 
particularly needy subject population. 
The Spanner has not been withdrawn from marketing in any country for reasons relating 
to device safety and effectiveness.   
7 RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE 
AND CLINICAL INVESTIGATION 
7.1 
Anticipated Clinical Benefits 

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Men suffering from urinary retention due to an enlarged prostate and who are unfit for 
pharmacologic, minimally invasive or surgical treatment often have no alternative to 
relieve urinary retention other than catheterization.  The Spanner is a completely internal 
stent that provides a means for these subjects to achieve normal micturition and avoid 
the known and serious complications that occur due to the urinary catheter’s external 
components. The fully internal design of The Spanner has also been shown to improve 
subject quality of life. 
7.2 
Anticipated Adverse Device Effects 
Based on the device design and intended use, the intended subject population, and 
experience with similar urological devices, the following list of potential risks and adverse 
events may be related to use of the device. 
 
Micturition burning/pain; 
 
Urinary frequency; 
 
Urgency; 
 
Perineal/urethral pain; 
 
Bacteriuria; 
 
Symptomatic urinary tract infection; 
 
Urinary retention with no reported migration or clotting; 
 
Urinary retention associated with migration; 
 
Urinary retention associated with clotting; 
 
Urinary incontinence; 
 
Pain – trauma activated; 
 
Ejaculation failure; 
 
Dyspareunia – painful sex; 
 
Urinary hesitation; 
 
Ulceration, erosion, or trauma of the bladder or urethra; 
 
Dysuria, pain or spasm of the bladder or urethra; 
 
Microscopic or gross hematuria or bleeding; 
 
Elevated post void residual urine; 
 
Purulent urethral discharge; 
 
Encrustation of the device or device sutures; 
 
Irritation of the bladder or urethra from contact with the device; 
 
Upper tract deterioration. 
7.3 
Anticipated Device Deficiencies 
The following are device deficiencies that may occur during the conduct of the 
investigation.  All device deficiencies should be reported as Adverse Events, as 
described in Section 21. 
 
Device malfunction including balloon deflation or non-deflation, balloon breakage, 
breakage of the removal suture or the suture connecting the stent to the distal 
anchor; 
 
Migration of the device or the removal suture; 
 
Expulsion of the device. 

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7.4 
Risks Associated With Participation in the Clinical Investigation 
In addition to device related risks, participants will receive a cystoscopy at visits one and 
four.  Cystoscopy is a commonly performed urological procedure.  Adverse effects can 
include infection, bleeding and pain associated with the cystoscopy.    
Some of the possible side effects of anesthetic medication in the urethra include allergic 
reactions which may include coughing, difficulty swallowing, rash, hives, or swelling.  
Other possible side effects include high or low blood pressure, stomach upset, tingling 
sensations in the skin, dizziness, decreased heart rate, and death.  
Having blood samples taken from a vein may cause temporary pain or bruising.  It is 
possible for the skin at the puncture site or the vein to become irritated and inflamed.  
On rare occasions, blood clot formation, bleeding at the puncture site, or infection could 
occur.  
7.5 
Possible Interactions with Concomitant Medical Treatments 
The Spanner device is placed in the urethra and bladder neck and is a physical obstacle 
to potential medical treatments that involve cystoscopy of the urethra, bladder or 
kidneys.  The Spanner would need to be removed prior to such medical treatments.  The 
Spanner has not been evaluated for use with an MRI.  If an MRI is needed, The Spanner 
should be removed. 
7.6 
Residual Risks  
The residual risks have been addressed through a risk assessment performed for the 
device, both from a Failure Mode Effects Analysis and through prior clinical 
investigations.  Risks associated with the device and procedure have been mitigated 
through numerous mechanisms including design, inspections, protocol mechanisms, 
physician and study personnel training, frequent subject follow up, and study monitoring.  
The potential benefits are significant and offset the remaining residual risks. 
7.7 
Mitigation of Risks 
The following measures will be taken to minimize risks to subjects participating in the 
trial: 
 
Study participants will be provided thorough verbal and written instructions and 
warnings for use of the study device, and they will be instructed in the 
appropriate actions to take, including notification of the investigator in the event 
of adverse effects or malfunction of the study device. 
 
Participants will be examined and interviewed at regularly scheduled visits to 
determine the presence of signs or symptoms indicating possible adverse effects 
or malfunction of the study device. 
 
Urinalysis and urine cultures will be taken at prescribed intervals to monitor for 
hematuria, bacteriuria and symptomatic urinary tract infections. 
 
Renal function will be monitored in all subjects at all time points during the study 
by monitoring serum creatinine levels at each visit. 

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 
Sponsor procedures will be in place to provide for timely, ongoing investigation of 
adverse events in order to allow appropriate actions to be taken if unanticipated 
events occur.   
 
The Sponsor will perform regular periodic visits to each participating site, 
reviewing all participant files to assure timely detection of unanticipated device 
effects or outcomes. 
 
Selection of experienced urologists. 
 
The protocol clearly defines the subject inclusion/exclusion criteria and subject 
treatment and follow-up that are consistent with current medical practices. 
 
The Spanner has been designed and developed within a quality management 
system that is compliant with the applicable requirements. 
7.8 
Risk-to-Benefit Rationale 
Subjects who are bothered by utilizing a urinary catheter for bladder drainage and who 
are not candidates for prostatic treatments are offered a temporary alternative to their 
urinary catheter. Data from prior studies indicates that a high percentage of subjects who 
meet the inclusion criteria benefit from the procedure.  For the majority of the subjects 
the benefit of the procedure outweighs the risks. 
8 OBJECTIVES AND HYPOTHESES OF THE CLINICAL 
INVESTIGATION 
8.1 
Primary Objective 
The primary objective of the clinical study is: 
 
To determine the proportion of subjects who achieve adequate bladder drainage 
over 90 days, defined as a post-void residual (PVR) of ≤150 ml.  
 
The pre-specified success criterion for this study is that ≥50 percent of subjects 
will achieve adequate bladder drainage over 90 days. 
8.2 
Secondary Objectives 
The secondary objectives of the clinical study are: 
 
To measure the effects of the Spanner stent on bladder drainage, defined by: 
 
The proportion of subjects who achieve a post-void residual (PVR) of ≤150 ml 
over 30 days.  
 
The proportion of subjects who achieve a post-void residual (PVR) of ≤250 ml 
over 30 days.  
 
The proportion of subjects who achieve a post-void residual (PVR) of ≤250 ml 
over 90 days.  
 
To measure the effects of the Spanner stent over time on maximum flow rate 
(Qmax in ml/sec) as assessed by Uroflow   
 
To measure the effects of the Spanner stent over time on the International 
Prostate Symptom Score (IPSS) 

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8.3 
Study Hypotheses  
8.3.1 Primary Endpoint: Assessment of PVR over 90 days 
PVR levels will be monitored throughout the 90 days of stent use to confirm that the 
subject is able to successfully empty his bladder. PVR levels are assessed on Visits 1, 2, 
3 and 4 while stent is in place using abdominal ultrasound.  The hypothesis is that over 
90 days of stent use, 50% of the subjects will be able to successfully empty their 
bladder, as defined by PVR of <150 ml at all four visits.   
8.3.2 Secondary Endpoints: Other Assessments of PVR 
The monitored PVR levels at Visits 1, 2, 3, and 4 will be further assessed as follows: 
 
The proportion of subjects over 30 days (Visits 1 and 2) with PVR <150 ml. 
 
The proportion of subjects over 30 days (Visits 1 and 2) with PVR <250 ml. 
 
The proportion of subjects over 90 days (Visits 1-4) with PVR <250 ml. 
8.4 
Adverse Events 
Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Unanticipated Adverse 
Device Effects (UADEs), to be documented from time of enrollment until the last study 
visit.   
8.4.1 Exploratory Endpoints 
 
Qmax scores. 
 
IPSS scores.  
9 DESIGN OF THE CLINICAL INVESTIGATION 
The proposed investigation will be a prospective, multicenter, single-arm, open-label 
trial.   
The study will be conducted at three to ten study centers in the US.  Subjects will be 
enrolled in the trial for a period of up to 125 days, which includes up to 20 days of post-
removal follow-up prior to study discharge.  The objectives of the statistical analyses are 
to: 
 
Assess the effectiveness of the device in emptying of the bladder 
 
Assess the safety of the device in the population under study 
The study will enroll approximately 105 subjects who are dependent on a urinary 
catheter and meet eligibility criteria.  The study will consist of a 90 day treatment period.  
Subjects will be fitted with a Spanner stent and the stent will be replaced at an interval of 
approximately 30 days (25-35 days permitted) for a total of up to 90 days of use (75-105 
days permitted).  Subjects will complete the study upon removal of the Spanner stent 
after 90 days and one follow-up telephone call post-removal. 
All participants will undergo approximately 90 days of Spanner use, in the form of 
consecutive Spanner placements each lasting approximately 30 days (25-35 days 
permitted).  During the 90 days, data will be collected with respect to PVR, uroflow, 

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urinary symptoms, subject satisfaction and the occurrence of adverse events.  
Cystoscopy will be performed prior to the initial stent placement and after the final stent 
removal to determine any effects of The Spanner on lower urinary tract anatomy. 
9.1 
Measures to Avoid Bias  
 
The investigators are independent from the sponsor and are experienced with 
similar procedures. 
 
The study uses standardized measurements for endpoints. 
 
The disposition of all screened subjects will be recorded.  
 
Analyses to address primary and secondary objectives will be performed using 
an intention-to-treat sample including all enrolled subjects who underwent an 
attempted Spanner device implant procedure. 
 
The study will be monitored by independent individuals qualified by education 
and experience. 
9.2 
Primary and Secondary Endpoints 
Primary and secondary endpoints have already been described in CIP Section 8. 
9.3 
Methods and Timing for Assessing, Recording, and Analyzing Variables 
Timing of testing and events is provided in Section 12.1 Study Activities Table.  Data 
assessment and analysis is described in Section 14. Statistical Considerations.  
Guidance for the categorization of adverse events is provided in Section 21.6 Managing 
Adverse Events. Recording guidance is provided in Section 15.1 Electronic Case Report 
Form Completion.  The requirements for conducting and reporting uroflow are defined in 
Attachment B. 
9.3.1 Requirements for Diagnostic and Laboratory Tests 
9.3.1.1 Urinalysis (UA), Urine Culture and Sensitivity (UC&S) and Serum Creatinine 
 
Test Laboratory 
Testing must be completed by an accredited laboratory.  Documentation of accreditation 
of the laboratory must be provided to the study Sponsor prior to study initiation.  A copy 
of the laboratory normal ranges must also be supplied to the Sponsor. 
 
Specimen Collection, Handling & Analysis Requirements  
 
Clean catch, voided, mid-steam urine samples of adequate volume (50 ml 
minimum) should be collected in sterile containers and forwarded promptly to the 
testing lab.  If clean catch is not practical due to urinary retention, use a straight 
catheter to directly drain the bladder.  
 
Urinalysis with microscopy – A complete microscopic examination is required in 
addition to the routine urinalysis.  Specifically, counts of white cells (WBC), red 
cells (RBC) and bacteria present in the sample are required. 
 
Urine culture – Required when Urinalysis suggests microbial infection. For 
positive urine cultures, the organism identification as well as the colony count 
must be provided. 

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 
Serum Creatinine- A serum creatinine blood test is required to monitor renal 
function throughout the study.   
9.3.1.2 Post Void Residual Urine (PVR) Testing 
PVR will be determined using abdominal ultrasound: 
 
Subjects with a minimum PVR > 350 ml will be prematurely removed from the 
study (see Section 21.5.8). 
 
Subjects with a minimum PVR greater than 250 ml (and less than 350 ml) will be 
scheduled for a follow-up visit within one week to monitor PVR.  
9.4 
Randomization 
The study design is a non-randomized single-arm design.   
9.5 
Pooling of Study Centers 
All statistical analyses will be conducted using overall analyses pooled across all study 
centers.   
9.6 
Equipment Maintenance and Calibration 
During the site initiation and training visit SRS will assure maintenance and calibration of 
the equipment relevant for the assessment of the clinical investigation is performed and 
documented. 
9.7 
Procedures for Replacement of Subjects 
Enrolled subjects will not be replaced. 
10 EXPOSURE TO INVESTIGATIONAL DEVICES AND 
MEDICATIONS 
10.1 Exposure to the Investigational Device 
Subjects will use The Spanner for approximately 90 days, in the form of three 
consecutive Spanner placements each lasting approximately 30 days.  The current US 
labeling of The Spanner does not anticipate the replacement of the initial stent after 30 
days. 
This is a single-armed clinical study so the study subjects will not be exposed to 
comparators. 
10.2 Recommended Medications  
10.2.1 Use of Urinary Tract Medications  
Urinary tract medications may be continued, discontinued or initiated during the study 
period.  Record the use of these medications on the eCRF system.  Note that the use of 
certain urinary tract medications (anticholinergics and BPH medications) are prohibited 
from use during the study. 

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10.2.2 Use of Antibiotic Coverage  
Men participating in the study will receive antibiotic coverage throughout the study, 
based on the investigator’s antibiotic of choice after reviewing the scheduled urine 
cultures.  Record the use of these medications on the eCRF system. 
10.2.3 Additional Medical Care 
Additional medical care in the form of medical office visits or home health care may be 
continued, discontinued or initiated during the study period.  Record all medical care on 
the eCRF system. 
10.3 Number of Investigational Devices Needed 
The total sample size of n=105 subjects will be required for the study.  Each subject is 
scheduled to receive three consecutive Spanner stents.  Therefore, the estimated 
number of Spanners required for this study is 315.  
Each subject will be measured once using the Surveyor Urethral Measurement Device to 
confirm Spanner size.  The estimated number Surveyors used in the study is 105. 
11 SUBJECTS 
11.1 Inclusion Criteria 
 
Age > 45 years; 
 
In urinary retention and catheterized (indwelling or intermittent) for less than 180 
days; 
 
Documented diagnostic history (within 180 days of study) of detrusor contractility 
(>= 15 cmH2O) confirmed via pressure-flow test; 
 
Negative Urinalysis on Visit 1;  
 
Not a candidate for pharmacologic, minimally invasive or surgical treatment of 
the prostate; 
 
Charlson Weighted Index of Comorbidity Score >= 1 (see Attachment C); 
 
Willing and able to sign the Informed Consent Form 
 
Willing and able to complete the follow-up protocol requirements; 
 
Experiencing catheter-induced discomfort.  
11.2 Exclusion Criteria 
 
Current use of a urinary catheter daily for greater than 180 consecutive days 
immediately preceding entering into the study; 
 
Positive Urinalysis on Visit 1;  
 
Current or recent (within the last 6 months) urinary tract disease including 
urethral stricture, bladder stones, and other significant urological conditions or 
surgery; 
 
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy 
that affect the function of the lower urinary tract; 
 
History of conditions associated with neurogenic bladder, including spinal cord 
injury, multiple sclerosis, or Parkinson’s disease; 

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 
Use of anticholinergic medication; 
 
Gross hematuria when catheter is removed on Visit 1; 
 
Known or suspected prostate cancer; 
 
Prior pelvic irradiation therapy; 
 
Prostatic urethral length < 4 cm or > 9 cm (combined length from the top proximal 
side of the bladder neck to the bottom distal side of the external sphincter) 
 
Intravesical enlargement of the median lobe of the prostate. 
 
Prior penile prosthesis 
11.3 Subject Withdrawal or Discontinuation 
Premature withdrawal of a subject from the study for any reason must be documented 
using the Study Completion eCRF.  Where possible, a final evaluation should be carried 
out including all of the evaluations specified for Visit 4.   
If a subject is withdrawn due to an Adverse Event, the final visit should be completed 1 
week after resolution of the Adverse Event. If a subject is unable or unwilling to complete 
all of the required evaluations, obtain as many as possible.  In addition, if the withdrawal 
is associated with an Adverse Event, follow the procedures described in Section 21. 
Use the Unscheduled Visit eCRF to record the results of the evaluation. 
11.4 Point of Enrollment 
Each study candidate to be evaluated during screening will be asked to sign an Informed 
Consent Form (ICF) prior to the conduct of study specific procedures.  The ICF outlines 
the study procedures, investigational nature of the study, protocol responsibilities, and 
the expected risks vs. benefits of participation.   
Screening is planned to be conducted entirely at Visit 1.Subjects who meet the inclusion 
and exclusion criteria are enrolled in the study.  Device insertion is also planned to be 
conducted at Visit 1. 
The Investigator will retain a Screening Log of those who are considered candidates for 
enrollment.  If a subject later declines or is excluded from enrollment, the Investigator will 
note the reason for non-participation in the log.  Potential subjects will be identified in the 
log by their initials only.  

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Figure 9. Flowchart of Subject Screening, Enrollment and Spanner Insertion 
 
 
 
 
 
 
 
 
 
 
eCRF01 
 
 
 
 
 
 
 
 
 
 
 
 
eCRF02 
 
11.4.1 Positive Urinalysis Treatment and Rescreening 
Subjects who are excluded as a result of a positive urinalysis may treated and 
rescreened at a future visit. 
11.5 Expected Individual Subject Participation and Total Duration of the Clinical 
Investigation 
The estimated time needed to meet the enrollment requirement is 4 months. 
The study will consist of a 90 day treatment period.  Subjects may be screened and fitted 
with a Spanner stent at Visit 1.  The stent will be replaced at an interval of approximately 
30 days (25-35 days permitted) for a total of up to 90 days of use (75-105 days 
permitted).  Subjects will complete the study upon removal of the Spanner stent after 90 
days and one follow-up telephone call post-removal. 
The Spanner Temporary Prostatic Stent Study Flowchart – Screening All Patients 
Requires Presenting Symptoms: 
Men not candidates for pharmacologic, minimally invasive or surgical treatment of the prostate 
who are in urinary retention and catheterized (indwelling or intermittent) for less than 180 days. 
Explain Study 
Obtain Informed Consent Form 
Medical History and Physical Examination 
Urinalysis and Urine Culture (if indicated) 
Cystoscopy 
Meets Inclusion/Exclusion Criteria? 
No   
Exclude 
Yes 
Spanner Insertion 

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The expected total duration of this clinical investigation is 8 months. 
11.6 Number of Subjects Required  
Assuming a dropout rate of 20%, the total sample size of n=105 subjects will be required 
for the study. 
12 PROCEDURES 
12.1 Study Activities Table 
The study activities are listed in Table 5.  Further descriptions of the study activities are 
provided in this section 
Table 5.  Study Activities 
Activity 
Visit 1 
Screening, 
End of 
Catheter use 
 
(Stent #1 
Placement) 
Visit 2 
1 Month 
 
(Stent #1 
Removal.  
Stent #2 
Placement) 
Visit 3 
 
2 Month 
(Stent #2 
Removal.  
Stent #3 
Placement) 
Visit 4 
3 Month 
 
(Stent #3 
Removal) 
Follow-up 
Phone Call 
Visit Windows 
Not 
Applicable 
30 + 5 
days 
30 + 5 days 
30 + 5 
days 
15-20 days 
post 
Final Stent 
Removal 
Informed Consent 
√ 
 
 
 
 
History and 
Physical with 
DRE 
√ 
 
 
 
 
Urinalysis with 
Micro 
√ 
√ 
√ 
√ 
 
Urine Culture & 
Sensitivity (If 
indicated) 
√ 
√ 
√ 
√ 
 
Uroflow  
√ 
√ 
√ 
√ 
 
PVR 
√ 
√ 
√ 
√ 
 
Subject 
Satisfaction 
Questionnaire 
√ 
√ 
√ 
√ 
 
IPSS 
 
√ 
√ 
√ 
 
Cystoscopy 
√ 
 
 
√ 
 
Patient is 
enrolled 
√ 
 
 
 
 
Urethral length 
measurement  
with Surveyor 
√ 
 
 
 
 
Stent Placement 
√ 
√ 
√ 
 
 
Serum Creatinine 
√ 
√ 
√ 
√ 
 
Adverse Events 
√ 
√ 
√ 
√ 
√ 
Discharge  
 
 
 
 
√ 

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12.1.1 Visit 1: Screening, End of Catheter Use and Stent #1 Placement 
 
Obtain informed consent.  
 
Obtain the medical history and perform a physical examination including a digital 
rectal examination.  
 
Confirm that subject is not taking anticholinergic medication to manage bladder 
spasm (an exclusion criterion).   
 
To obtain a urine specimen: 
 
Remove the catheter 
 
Allow the subject to naturally fill his bladder 
 
Obtain and send a urine specimen for UA & UC&S if indicated.   
 
Confirm that the UA is negative. 
 
Perform cystoscopy and take two cystoscopy photographs: (a) of the bulbar 
urethra looking at a closed external sphincter, and (b) at the verumontanum 
looking towards the bladder. 
 
Subjects who meet the inclusion and exclusion criteria will be enrolled into the 
study. 
 
For directions for Spanner size selection and insertion refer to The Spanner 
Physician Instructions for Use (see Attachment A). Use the Surveyor urethral 
measurement device to determine the appropriate size Spanner.  
 
Insert the Spanner.  
 
Place cystoscope into bulbar urethra and confirm the proper location of the distal 
anchor.  If the Spanner was incorrectly sized, the stent can be removed and 
replaced with the proper size.  Replacement may occur one time only. 
 
Record any Adverse Event that occurred during sizing and Spanner insertion. 
 
Allow the subject to drink fluids and wait for a full bladder. Alternatively, 
investigator may choose to fill the bladder using cystoscopy (if cystoscopy filling 
is performed, note in the source and the eCRF system).   
 
With Stent #1 in place, perform the uroflow test followed by measurement of the 
PVR (abdominal ultrasound).  Refer to Attachment B for requirements for 
uroflow testing.   
 
Provide Subject Information Booklet for The Spanner (see Attachment D) to the 
subject.  Review each potential Adverse Event with the subject and the 
appropriate actions to be taken by the subject if they occur. 
 
Provide Subject Emergency Removal Card (see Attachment D) to the subject.  
Instruct the patient to provide the card to other care providers to inform them that 
the patient is wearing the Spanner.  
 
Obtain and send blood sample for serum creatinine. 
 
Have the subject complete the subject satisfaction questionnaire. 
 
Interview the subject for signs and symptoms of Adverse Events. 
 
Place test reports in the subject’s study file and record in eCRF..   
 
Schedule the subject to return for Visit 2 (in 25-35 days).  

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12.1.2 Visit 2: Stent #1 Removal and Stent #2 Placement 
 
Have the subject complete the subject satisfaction questionnaire and an IPSS 
survey. Instruct the subject that he should answer the questions about symptoms 
related to the timeframe between visits. 
 
Obtain and send a urine specimen for UA & UC&S (if indicated).  Place a copy of 
the test report in the subject’s study file and record in eCRF.   
 
Perform a uroflow test.  Measure and record the Qmax during the test. Refer to 
Attachment B for requirements for uroflow testing.  Place the uroflow report in 
the subject’s study file.   
 
Immediately following each uroflow test, measure the PVR using abdominal 
ultrasound.  Record the PVR with the corresponding uroflow test.  Note: If two 
uroflow tests were conducted PVR must be measured and reported for each test.   
 
Remove Stent #1 
 
Place Stent #2. 
 
Obtain and send blood sample for serum creatinine. 
 
Interview the subject for signs and symptoms of Adverse Events. 
 
Schedule the subject to return for Visit 3 (in 25-35 days).  
12.1.3 Visit 3: Stent #2 Removal and Stent #3 Placement  
 
Have the subject complete the subject satisfaction questionnaire and an IPSS 
survey. Instruct the subject that he should answer the questions about symptoms 
related to the timeframe between visits. 
 
Obtain and send a urine specimen for UA & UC&S (if indicated).  Place a copy of 
the test report in the subject’s study file and record in eCRF.   
 
Perform a uroflow test.  Measure and record the Qmax during the test. Refer to 
Attachment B for requirements for uroflow testing.  Place the uroflow report in the 
subject’s study file and record in eCRF.  
 
Immediately following each uroflow test, measure the PVR using abdominal 
ultrasound.  Record the PVR with the corresponding uroflow test.  Note: If two 
uroflow tests were conducted PVR must be measured and reported for each test.   
 
Remove Stent #2 
 
Place Stent #3. 
 
Obtain and send blood sample for serum creatinine. 
 
Interview the subject for signs and symptoms of Adverse Events. 
 
Schedule the subject to return for Visit 4 (in 25-35 days).  
12.1.4 Visit 4: Stent #3 Removal 
 
Have the subject complete the subject satisfaction questionnaire and an IPSS 
survey. Instruct the subject that he should answer the questions about symptoms 
related to the timeframe between visits. 
 
Obtain and send a urine specimen for UA & UC&S (if indicated).  Place a copy of 
the test report in the subject’s study file and record in eCRF.   

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 
Perform a uroflow test.  Measure and record the Qmax during the test. Refer to 
Attachment B for requirements for uroflow testing.  Place the uroflow report in the 
subject’s study file and record in eCRF.   
 
Immediately following each uroflow test, measure the PVR using abdominal 
ultrasound.  Record the PVR with the corresponding uroflow test.  Note: If two 
uroflow tests were conducted PVR must be measured and reported for each test.   
 
Remove Stent #3 
 
Perform cystoscopy and take two cystoscopy photographs: (a) of the bulbar 
urethra looking at a closed external sphincter, and (b) at the verumontanum 
looking towards the bladder. 
 
Obtain and send blood sample for serum creatinine. 
 
Interview the subject for signs and symptoms of Adverse Events. 
 
Schedule the subject for a follow-up phone call (in 15-20 days).  
12.1.5 Phone Call #1 
 
Via telephone, interview the subject for signs and symptoms of Adverse Events.  
Record information on the Adverse Event eCRF. 
 
 Discharge subject from study. 
NOTE: Any subject with an ongoing or unresolved adverse event may continue to be 
followed until the event is resolved.  The subsequent follow up and resolution should be 
documented on the Adverse Event eCRF.  
12.1.6 Unscheduled Visits 
If the subject returns to a medical facility due to a BPH or stent related issue, then 
complete an Unscheduled Visit eCRF. 

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12.1.7 Post Study Completion - Continued Access 
If, at the completion of all study visits, the Spanner is not yet approved for this indication, 
then the investigational device may be made available during the preparation and review 
of the marketing application, to allow enrolled subjects to extend their use of the device. 
These continued access visits will be conducted in compliance with the clinical 
investigational plan, ISO 14155, and 21 CFR Parts 812, 50, 54, and 56.  The study visits 
will be conducted by the delegated study staff using the eCRFs, including visit, 
unanticipated visit, and adverse event monitoring. There will be continued CRO 
oversight and monitoring during this entire continued access period and additional safety 
and effectiveness data will be collected. 
Subjects must have completed the requirements of the final telephone visit described in 
Section 12.1.5 above before obtaining voluntary continued access.  Subjects who 
volunteer for continued access will be required to attend monthly study visits (30 days +/- 
5 days) repeating the requirements of Visit 3 (the Continued Access Visit requirements 
are listed below). These visits may continue until use of the Spanner is no longer 
clinically indicated or desired, or until the Spanner receives marketing approval for this 
indication, whichever is sooner. 
12.1.7.1 Continuing Access Visits after Study Completion: Stent Removal and 
Placement  
 
Have the subject complete the subject satisfaction questionnaire and an IPSS 
survey. Instruct the subject that he should answer the questions about symptoms 
related to the timeframe between visits. 
 
Obtain and send a urine specimen for UA & UC&S (if indicated).  Place a copy of 
the test report in the subject’s study file and record in eCRF.   
 
Perform a uroflow test.  Measure and record the Qmax during the test. Refer to 
Attachment B for requirements for uroflow testing.  Place the uroflow report in the 
subject’s study file and record in eCRF.  
 
Immediately following each uroflow test, measure the PVR using abdominal 
ultrasound.  Record the PVR with the corresponding uroflow test.  Note: If two 
uroflow tests were conducted PVR must be measured and reported for each test.   
 
Remove Stent  
 
Place Stent. 
 
Obtain and send blood sample for serum creatinine. 
 
Interview the subject for signs and symptoms of Adverse Events. 
 
Schedule the subject to return for next Visit (in 25-35 days).  
 
12.2 Foreseeable Factors that May Compromise the Outcome of the Clinical 
Investigation  

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Use of anticholinergic medication to manage bladder spasm is an exclusion criterion.  
Subjects taking anticholinergic medication are asked to discontinue use of the 
medication for the duration of the study. 
The inclusion assessment requires evidence of detrusor muscle contractility.  Subjects 
entering the study with poor bladder contractility could result in unanticipated device 
failures.   
13 MONITORING PLAN 
13.1 Monitor Name and Address 
The monitoring of study sites and the audit functions will be the responsibility of the 
study sponsor or their designee(s): 
 
SRS Medical Systems, Inc. 
76 Treble Cove Road, Building 3 
North Billerica, MA  01862 
 
13.2 Monitor Responsibilities 
A sponsor may designate one or more appropriately trained and qualified individuals to 
monitor the progress of a clinical investigation. A monitor need not be a person qualified 
to diagnose and treat the disease or other condition for which the test article is under 
investigation, but somewhere in the direct line of review of the study data there will be a 
person so qualified.   
Each monitor will be trained on monitoring per Standard Operating Procedures (SOPs), 
the protocol and protocol-specific monitoring plan prior to conducting any study-specific 
activities.   
13.3 Procedures 
SRS Medical is responsible to ensure that the study is monitored and to confirm proper 
conduct and progress of the study including adequate protection of human subjects and 
the integrity of the clinical study data is of the highest quality.  The sponsor shall assess 
the extent and nature of monitoring appropriate for the clinical investigation, including the 
strategy for source data verification, based on considerations such as the objective, 
design, complexity, size, critical data points and endpoints of the clinical investigation. 
Results of this assessment shall be used to develop a monitoring plan. 
The monitor shall have access to the source documents and other information needed to 
ensure investigator compliance with the clinical investigation plan and applicable rules 
and regulations, and to assess the progress of the clinical investigation.  
Site visits will be made before the study begins, at regular intervals during the study, and 
at the study closeout. Communication by telephone, mail, and e-mail may be used as 
needed to supplement site visits. The investigator and study personnel will cooperate 
with the sponsor and their representatives, provide all appropriate documentation, and 
be available to discuss the study. 

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13.4 Monitoring and Audit Visits 
Site visits will be made before the study begins, at regular intervals during the study, and 
at the study closeout. Communication by telephone, mail, and e-mail may be used as 
needed to supplement site visits. The Investigator and study personnel will cooperate 
with the sponsor and their representatives, provide all appropriate documentation, and 
be available to discuss the study.  Adequate time and space for these visits should be 
allocated by the investigator.  
According to the guidelines on Good Clinical Practice, the monitor will check the CRF 
entries against the source documents. The consent form will include a statement by 
which the subjects allow the sponsor’s duly authorized personnel to have direct access 
to source data which supports data on the case report forms (e.g.: medical records, 
clinic charts and office notes, appointment books, original laboratory records, uroflow 
printouts, cystoscopy reports, etc.). These personnel, bound by professional 
confidentiality, will not disclose any personal identity or personal medical information 
outside of the realm of study data.  
The monitoring and auditing visits may include but are not limited to the following:  
13.4.1 Site Qualification and Site Initiation Visit  
The Site Qualification Visit enables SRS Medical to determine acceptability of site for 
subject population, expected enrollment, appropriate space for study equipment 
including limited access to investigational product and availability of an accredited 
clinical laboratory. These visits also determine the qualification and availability of 
investigator, sub-Investigators, and support staff, staff’s previous clinical research 
experience, and the monitoring requirements. This visit will be documented in a site 
qualification report. This visit may be completed on site or remotely.  Investigation site 
selection rationale can be based on prior experience of the sponsor with the principal 
investigator or the investigation site. Previously used sites may not require an addition 
qualification visit however justification for their use will be documented.   
During the Site Initiation Visit (or Investigator Meeting), a review of the CIP, discussion of 
the Investigator’s Brochure and discussions on the function/use of the system/equipment 
with the investigator/staff will occur.  Should the PI choose to delegate study related 
tasks to qualified personnel under their direct supervision, this will be documented on the 
Delegation of Authority Log that will include names, initials, signatures, functions, and 
designated authorizations for the principal investigator and members of the investigation 
site team. In addition, delegated site personnel must be trained on the study relative to 
the tasks that have been assigned to them and this will be documented on the training 
log.   
Before enrolling any subjects in this study, site personnel and the investigator will be 
trained on the protocol, the CRFs and instructions for their completion, the procedure for 
obtaining informed consent, and the procedure for reporting AEs, SAEs, SADEs and 
UADEs.  

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13.4.2 Interim Monitoring Visits 
Interim monitoring visits are made periodically per the monitoring plan to assess the 
investigator’s adherence to the CIP, IRB requirements, maintenance of records and 
reports and review of source documents for accuracy, completeness, legibility, 
omissions and equipment calibration records.  In cases where the site is not able to 
grant the monitor access to the electronic medical record, the investigational site staff 
will obtain copies of the electronic medical record and number the pages consecutively, 
sign and date the packet to indicate they are certified copies of the medical record.  The 
monitors will acquire information to assess the progress of the study (toward meeting 
study objectives) and identify any concerns that stem from observation of device 
performance and/or review of the investigator’s subject records, study management 
documents, regulatory documents, device tracking and verifying each subject has signed 
informed consent documents.  Resolution of outstanding issues and completion of 
assigned tasks will be documented by the monitors. The Investigator agrees to 
accommodate and be available at monitoring visits conducted at a reasonable time in a 
reasonable manner, as needed.   
13.4.3 Close Out Visit 
The monitor will conduct a final Close-Out Visit at the sites for all sites.  If investigational 
product remains at the site then a site visit is required to collect and document the return 
of any unused investigational products.  A remote close out visit may occur at sites 
where investigational product has never been shipped or final device reconciliation has 
been completed at previous monitoring visits.  Close out visits instruct the site on 
adherence to record retention requirements, ensure final data has been reconciled and a 
final monitoring report, to include the study status at the site, shall be prepared by the 
monitors (or designates).  
Routine close-out activities shall be conducted to ensure that the principal investigator's 
records are complete, all documents needed for the sponsor's files are retrieved, 
remaining clinical investigation materials are retrieved or disposed of, previously 
identified issues have been resolved and all parties are notified including the EC and 
regulatory authorities, if required. 
Ensure that: 
 
essential documents are complete and up to date, 
 
CRFs are completed, 
 
outstanding queries are resolved, 
 
the current status of all ongoing adverse events is documented, 
 
arrangements are made for archiving and record retention, and 
 
disposition of investigational devices and other clinical investigation materials is 
documented. 
13.4.4 Site Audits 
SRS Medical may choose to perform random audits throughout the study as part of 
implementing quality assurance.  The purpose of this audit (which is independent of and 
separate from routine monitoring or quality control functions) is to evaluate study 

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conduct and compliance with the protocol, applicable regulatory requirements, and 
study-specific procedures.  The plan for this audit may be guided by the number of 
subjects at the site and any identified problems (such as non-compliance to the 
protocol).  Non-compliance to the protocol and applicable regulatory requirements by the 
investigator/institution will lead to prompt action by SRS Medical to secure compliance.  
If the monitoring and/or auditing identify serious and or persistent non-compliance by the 
investigator/institution, SRS Medical may terminate the investigator/institution 
participation in the study.   
14 STATISTICAL CONSIDERATIONS 
This study is a multi-center, prospective, open-label, single-armed clinical study.   

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14.1 Level of Significance, Power and Sample Size  
A hypothesis test that the proportion of successes in the treatment group is statistically 
significantly greater than 50% will be computed.  In order to have an 80% chance of 
showing that the success proportion in the Spanner group is statistically significantly 
greater than 50%, assuming that the device can achieve a 65% success rate, with 
=0.05, a sample size of n=85 completers will be needed for the study.  The sample size 
calculation was based on an exact binomial one sample test.  
14.2 Expected Drop-out Rates 
Assuming a dropout rate of 20%, the total sample size of n=105 subjects will be required 
for the study.  A hypothesis test that the proportion of successes in the treatment group 
is statistically significantly greater than 50% will be computed.   
14.3 Primary Effectiveness Variable and Pass/Fail Criteria 
The primary effectiveness endpoint is the success/failure of the subject to have a 
successful urinary void at all four study visits: (a) upon initial placement of the first stent 
(Visit 1), and (b) at all three visits in which the subject has a stent placed for 30 days 
(Visits 2, 3 and 4).  
The primary effectiveness endpoint will be marked as a failure for a subject if any of the 
following occur: 
 
PVR of >150 ml at any visit (Visits 1, 2, 3, and 4) 
 
The subject withdraws from the trial 
14.4 Secondary Effectiveness Variable 
The secondary effectiveness variables for this study are: 
 
PVR through the first removal visit is ≤150 ml of urine (Visits 1 and 2) 
 
PVR through the first removal visit is ≤250 ml of urine (Visits 1 and 2) 
 
PVR through the third removal visit is ≤250 ml of urine (Visits 1-4) 
14.5 Exploratory Effectiveness Variable 
The exploratory effectiveness variables for this study are: 
 
Qmax measurement 
 
IPSS Total Symptom Score 
Qmax measurements will be taken from the initial stent placement forward (Visits 1, 2, 3 
and 4), while the IPSS instrument will be administered from the initial stent removal 
forward (Visits 2, 3, and 4).  Qmax and IPSS scores will be the change from baseline 
values (Visit 1 for Qmax and Visit 2 for IPSS).  
14.6 Safety Variables 
Safety variables that will be recorded are: 
 
Treatment emergent adverse events deemed to be related to the implantation 
procedure 

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 
Treatment emergent adverse events deemed to be related to the device 
 
All other adverse events 
14.6.1 Analysis Populations 
The following analysis populations will be defined.   
 
Intent-to-Treat (ITT) Population – The ITT population will consist of any enrolled 
subject who underwent an attempted Spanner device implant procedure. 
 
Per Protocol (PP) Population – The PP population will consist of all subjects who 
are enrolled in the study, have been implanted with a Spanner device, and have 
completed all study visits with no major protocol deviations while enrolled in the 
study2. 
 
Safety Population – The safety population will consist of all subjects who are 
enrolled in the study. 
The analysis of the primary and secondary efficacy endpoints will be conducted on ITT 
and PP populations.  The primary analysis set will be the ITT analysis.  All safety 
analyses will be conducted on the safety population.   
The study subjects to be excluded from the PP analysis set and the reasons for their 
exclusion will be determined and documented prior to statistical analysis.  These 
decisions will not be outcome-data driven.  
14.6.2 Analysis of Baseline and Demographic Characteristics 
Baseline and demographic characteristics will be summarized for all subjects in the 
safety population.  Continuous variables will be displayed via summary statistics (mean, 
median, sample size, standard deviation, minimum, and maximum).  Categorical 
variables will be summarized via counts and percentages. 
14.6.3 Analysis of the Primary Effectiveness Variable 
The following hypotheses will be tested at a one-sided α=0.025 level of significance: 
 
Ha0: ps ≤ 50%    vs.    Ha1: ps  > 50% 
 
where ps is the proportion of subjects with maintenance of successful voiding during the 
Spanner implantation period.  This hypothesis will be tested using a one-sample exact 
binomial test.  Summary statistics (counts and percentages) will be computed on the 
primary endpoint along with a 95% confidence interval on the treatment group success 
proportion. 
                                               
2 A major protocol deviation is defined as any protocol deviation that may affect the primary 
endpoint.   

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14.7 Analysis of the Secondary Effectiveness Variables 
The statistical analysis of the secondary effectiveness variables will be described in the 
Statistical Analysis Plan (SAP) document for the study.  The SAP will be completed and 
signed by the Sponsor before the enrollment of the first subject in the study. 
14.8 Analysis of Safety Variables 
All adverse events (AEs) will be observed for each subject from enrollment until 
termination from the study.  A treatment emergent adverse event is defined as an 
adverse event whose start date is on or after the procedure date.  If the procedure date 
and/or the AE start date are missing, the AE will be considered treatment emergent.  
Prior to analysis, all adverse events (AEs) will be coded using the Common Terminology 
Criteria for Adverse Events (CTCAE).  All AEs will be listed.      
14.8.1 Interim Analyses 
No formal interim analyses will be conducted during this study.   
14.9 Specification of subgroups for analysis 
None planned 
14.10 Reporting Deviations from the SAP 
Any deviations from the planned statistical analysis will be described and justified in the 
Final Study Report, if required. 
14.11 Treatment of Missing Data, Including Lost to Follow-up and Withdrawals 
For endpoint evaluations subjects with missing data due to missed visit, lost-to-follow-up 
or study withdrawal will have their missing data imputed using a multiple imputation 
method. Unless otherwise specifically noted, no statistical techniques will be used to 
impute missing values in other analyses of study data. 
14.12 The Number of Subjects at Each Center  
The study will be carried out at up to 10 clinical centers with a maximum of 45% of 
subjects enrolled at any one clinical center.  
15 DATA MANAGEMENT 
15.1 Electronic Case Report Form Completion 
Electronic case report forms (eCRFs) shall be developed to capture the data for each 
enrolled subject as required by the CIP. The eCRFs shall include information on the 
condition of each subject upon entering, and during the course of the clinical 
investigation, and exposure to the investigational device. 
It is the responsibility of the investigator to complete and maintain adequate and 
accurate eCRFs, which have been designed by the sponsor to record all observations 
and other pertinent data to the clinical investigation.  All information provided on the 
eCRFs must have source documentation in the subject’s chart in order to verify the data.  

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Any discrepancies shall be explained in writing. All observations relevant to the clinical 
evaluation will be entered on the appropriate eCRFs for each subject enrolled in the 
clinical study. All eCRFs will be signed by the Investigator or their designee.  
Once eCRFs have been reviewed by the monitor and collected from the study site, all 
corrections will be addressed through the query system provided with the data capture 
system.  The monitor or Sponsor will issue the queries to the site personnel at or 
between monitoring visits. 
All documents, eCRFs, photos or other subject data provided to SRS Medical will be de-
identified. The subject ID number, date and visit will be written on each document. All 
clinical data should be provided to the sponsor within 1 week of the visit/procedure/test 
or sooner if requested.   
15.2 Data Confidentiality 
Data is anonymized on data collection forms. Information sent to the sponsor is identified 
only by the assigned study ID number, initials, and age.  
Individual subject medical information obtained as a result of this study is considered 
confidential and disclosure to third parties is prohibited with the exceptions noted below.  
Subject confidentiality will be further ensured by utilizing identification code numbers to 
correspond to data in the study records and databases. The investigator will maintain a 
separate personal identification list or master list (which matches subject study 
identification numbers with their names) to enable records to be identified. This list will 
be maintained and stored in a secured location. The list will be accessed only by 
research study staff and will be destroyed after study completion as recommended by 
the IRB and Health Information Protection guidelines and national regulation.   
Medical information may be given to the subject’s personal physician or to other 
appropriate medical personnel responsible if required for the welfare of the subject if the 
subject provides such consent.  
15.3 Access to Data 
The Investigator / institution will permit trial related sponsor monitoring, audits, IRB 
review and regulatory inspection, providing direct access to all related source data / 
documents.  Electronic case report forms and all source documents, including progress 
notes and copies of laboratory and medical test results will be available for review by the 
sponsor, the IRB and the FDA. Subjects will be informed that the IRB and the FDA will 
have access to this information when requested for inspection.  
During regular business hours and upon reasonable prior notice to the site the sponsor’s 
authorized representative(s) and governmental regulatory authorities shall, to the extent 
permitted by law, be permitted to: 
 
Examine and inspect the site’s facilities for performance of the study to monitor 
compliance with the protocol; and 
 
Inspect and copy all data and work products relating to the study (with a de-
identifying process after copying, to ensure no identified material leaves the 
institution). 

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Site shall cooperate with any other regulatory authority with appropriate jurisdiction, and 
with sponsor's prior notice, allow them access to applicable records and data.   
15.4 Data Review, Database Cleaning and Queries 
The sponsor clinical personnel or designee(s) will review the data for legibility, 
completeness, and logical consistency. Requests for data clarification or correction are 
forwarded to the investigative site for resolution.  
All documents and data shall be produced and maintained in a way that assures control 
and traceability. Where relevant, the accuracy of translations shall be guaranteed and 
documented. All documents, and subsequent versions, related to a clinical investigation 
shall be identifiable, traceable and appropriately stored to provide a complete history of 
the clinical investigation. SRS Medical or designee’s standard operating procedures, 
work procedures and forms for data management, treatment of data, source data 
verification, data archiving and retention procedures will be used in the conduct of the 
trial. 
Written procedures shall be implemented to:  
a) establish and document requirements for the electronic clinical data system to 
receive and process data, 
b) verify and validate that the requirements for the electronic clinical data system 
can be consistently met, 
c) ensure attributability, completeness, reliability, consistency and logic of the 
data entered, 
d) ensure accuracy of reports, 
e) ensure that data changes are documented and that there is no deletion of 
entered data (i.e. maintain an audit trail, data trail, edit trail), 
f) maintain a security system that prevents unauthorized access to the data, both 
internally and externally, 
g) maintain a list of individuals who have access to the electronic data system as 
well as the dates of access and privileges granted to each user, 
h) ensure that all completed CRFs are signed by the principal investigator or 
authorized designee, 
i) maintain adequate backup, retention and retrievability of the data, and 
j) train users on proper use of the system. 
15.5 Database Development 
SRS Medical will perform or oversee all technical functions to design and program a 
database system to house the eCRF data that is compliant with 21 CFR Part 11 and 
relevant FDA guidance documents: 
 
Computerized Systems Used In Clinical Investigations 
 
E6 Good Clinical Practice: Consolidated Guidance 

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SRS Medical databases will incorporate data entry and verification, time-stamped audit 
trails, protection of human subjects, restricted access, visit and eCRF tracking, and data 
security at the component level.  SRS Medical will configure the database to allow data 
entry and record management from data collected on paper case report forms into 
electronic data entry screens.  
15.6 Database Validation 
Validation techniques used by SRS Medical are consistent with FDA’s guidelines 
applicable at the time of this study protocol. Each database must pass a series of 
standard tests that demonstrate the usability and correctness of the database system to 
approved specifications.  
15.7 Record Retention Period 
Investigators are required to maintain the records listed below in an orderly, retrievable 
file during and after the investigation for the following period: 3 years after the date that 
(1) the data is no longer needed for an FDA submission or (2) the date the investigation 
is completed or terminated whichever is longer.  The Investigator is advised to contact 
the Sponsor to confirm the status of the device prior to discarding records. 
 
All reports required in Section 21. 
 
All correspondence about the study with another investigator, the Sponsor, the 
IRB, and FDA.   
 
Documents evidencing each subject’s informed consent and reasons for use of a 
device without informed consent (if applicable). 
 
Each subject’s completed case report forms and source documents such as 
medical records and results of diagnostic tests. 
 
The protocol and protocol amendments (if applicable) with documents showing 
the dates and reasons for any deviation from the protocol (if applicable). 
 
Any additional records required by the reviewing IRB. 
16 AMENDMENTS TO THE CIP 
SRS will submit a supplemental application to the FDA and obtain approval for changes 
in the investigational plan that may affect the scientific soundness of the investigation or 
the rights, safety, or welfare of the subjects.  SRS will receive IRB approval when the 
change involves the rights, safety, or welfare of subjects.  
17 DEVIATIONS FROM THE CIP 
Investigators are required to conduct this study in accordance with the signed 
Investigator’s Agreement this investigational plan, applicable laws and FDA regulations, 
and any conditions of approval imposed by the reviewing IRB and FDA. CIP deviation is 
defined as failure to follow, intentionally or unintentionally, the requirements of the 
protocol and associated documents.  The investigator is not allowed to deviate from the 
CIP except with prior approval or under emergency circumstances. All deviations shall 
be documented on an eCRF and explained, regardless the reason for the deviation.  

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17.1 Notification Requirements  
According to FDA regulation 21 CFR 812.150(a)(4), an investigator shall notify the 
sponsor and the reviewing IRB of any deviation from the investigational plan to protect 
the life and physical well-being of a subject in an emergency.  Such notice shall be given 
as soon as possible, but in no event later than five working days after the emergency 
occurred.  This information must also be included in the final study report to the IRB.  
Except in such an emergency, prior approval by the sponsor and the IRB are required 
for any change in or deviations from a plan.  If these changes or deviations could affect 
the scientific soundness of the plan or the rights, safety or welfare of human subjects, 
FDA approval is also required in accordance with 21 CFR 812.35(a).  If the investigator 
uses a device without informed consent, the investigator shall report this to the IRB 
within 5 working days of the occurrence.   
17.2 Corrective and Preventive Actions and Principal Investigator Disqualification 
Criteria 
If noncompliance with the study protocol or Investigator’s Agreement is found during a 
site visit, a discussion regarding the non-compliance will occur with the investigator or 
his/her staff at the time, determining corrective action, and obtaining the investigator’s 
concurrence. Shipment of additional devices will not occur until nonconformities are 
addressed. Documentation of the activity will be included on the monitoring visit report. 
Serious repetitive violations of the study protocol or Investigator’s Agreement may 
warrant exclusion from the study.  Serious violations include, but are not limited to: 
 
enrolling subjects without informed consent 
 
enrolling subjects who do not meet the inclusion/exclusion criteria 
 
failure to follow procedures called out by the protocol 
 
failure to report adverse events 
 
failure to submit the reports required under 21 CFR 812.150(a) or maintain the 
records required under 21 CFR 812.140 (a) 
A decision for exclusion will be made by Clinical Affairs, Regulatory Affairs and SRS 
management, and documented in the administrative file. The investigator and the 
reviewing IRB for the site will be notified in writing.  FDA will be notified of any such 
action and the reason for the action. Unused investigational device supplies will be 
withdrawn from an excluded site.   
17.3 Procedure for Analyzing CIP Deviations 
SRS Medical will analyze the documented deviations based on frequency and 
significance, and identifying any necessary corrective and/or preventive action (e.g. 
amending the CIP or to terminate the study early) internally and with the clinical 
investigator(s) and report them in the CRFs and in the final report. 
If significant non-compliance is identified, prompt action to either secure compliance, or 
discontinue shipments of the device to the PI and terminate the site’s participation in the 
study will be performed if applicable.  In circumstances of study termination, SRS 

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Medical will also require that the PI return the investigational devices, unless this action 
would jeopardize the rights, safety, or welfare of a subject. 
18 INVESTIGATIONAL DEVICE DOCUMENTATION AND 
SHIPPING 
18.1 Labeling 
The investigational system shall bear a label with the following information: the name 
and place of business of the manufacturer, packer, or distributor, and the quantity of 
contents, if appropriate.  The label, or other labeling, shall describe all relevant 
contraindications, hazards, adverse effects, interfering substances or devices, warnings, 
and precautions.   
19 STATEMENTS OF COMPLIANCE 
19.1 Statements of Compliance 
This clinical investigation shall be conducted in accordance with the ethical principles 
that have their origin in the Declaration of Helsinki3.  These principles protect the rights, 
safety and well-being of human subjects, which are the most important considerations 
and shall prevail over interests of science and society.  These principals shall be 
understood, observed and applied at every step of the investigation.  
This study will be conducted in compliance with clinical investigational plan, ISO 14155, 
and 21 CFR Parts 812, 50, 54, and 56.   
The clinical investigation shall not begin until the required approval/favorable opinion 
from the IRB and FDA approval of this CIP has been obtained via an IDE Application. 
Any additional requirements imposed by the regulatory authorities or the IRB shall be 
followed as appropriate 
19.2 Insurance 
Until the termination of the clinical trial or up to one year past explant of the last study 
participant, whichever is sooner, SRS Medical shall maintain comprehensive general 
liability insurance, including product liability insurance, underwritten by a reputable 
insurance carrier in an amount not less than 2 Million USD per occurrence and 2 Million 
USD in the aggregate. 
20 INFORMED CONSENT PROCESS 
The Informed Consent Form (ICF) includes the description for subject privacy for the 
study.  The template includes all aspects of the clinical investigation that are relevant to 
the subject’s decision to participate in the clinical investigation. This template must be 
customized for each investigational site to receive IRB approval of the ICF and final 
approval of the ICF by SRS Medical or designee. 
                                               
3 Declaration of Helsinki, available at http://www.wma.net 

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The consent form will be translated into the native language as required by local law, will 
not waive or appear to waive the subject’s legal rights, and will be written in non-
technical terms that would be understandable to subjects. The Principal Investigator (PI) 
or designee cannot seek the consent of prospective study subjects until the IRB has 
approved the current version of the Investigational Plan and the ICF. 
Prior to initiation of any study specific procedures, including screening and 
questionnaires, informed consent must be obtained in writing from the subject and the 
process shall be documented before any procedure specific to the clinical investigation 
is applied to the subject.  The IRB and SRS Medical approved ICF will be signed and 
dated by the subject.  A PI shall seek the consent only under circumstances that provide 
the prospective subject sufficient opportunity to consider all aspects of the study and 
whether or not to participate in the study and that minimize the possibility of coercion or 
undue influence. The subject will have the benefits and risks explained to them and will 
be given the opportunity to ask questions of the personnel conducting the study.  The 
ICF will be signed and dated by both the subject and the person conducting the consent 
process (PI or designee).  The signed ICF must be filed in the hospital/clinic medical 
chart or with the study subject documentation and be available for monitoring and 
auditing.  A copy of the signed ICF must be given to the subject for their records.  
If new information about the study or the medical device becomes available during the 
course of the study, the information will be provided to new and existing subjects, and if 
relevant, request existing subjects to confirm their continued participation in the study by 
signing a new informed consent. 
Due to the level of subject participation required for testing or training in the study, it is 
anticipated that all subjects will be able to make their own informed decision regarding 
participation and no vulnerable subjects will be enrolled in this study and the study 
device will not be used in emergency situations. 
21 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND 
DEVICE DEFICIENCIES 
21.1 Definitions 
21.1.1 Adverse Event- (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device. (ISO 14155:21011(E)).   
Note 1:  this definition includes events related to the investigational medical device or the 
comparator.  Note 2: This definition includes events related to the procedures involved.  Note 3: 
For users or the persons, the definition is restricted to events related to investigational medical 
devices  
An AE can be any unfavorable and intended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of an investigational 
product whether or not related to the investigational product (E6 Guidance).  

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All Device Deficiencies, whether resulting in a symptom or not, should be reported as an 
AE. 
An adverse event maybe further characterized as an ADE: 
21.1.2 Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device (ISO 
14155:2011(E)).  Note1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation or operation, or any 
malfunction of the investigational medical device. Note 2:  This definition includes any event 
resulting from user error or from intentional misuse of the investigational medical device. 
21.1.3 Anticipated Adverse Events 
 
Adverse event that was previously identified in nature, severity, or degree of 
incidence in the investigational /plan or application including supplementary plan 
or application or investigator’s brochure. 
 
Any normal expected post-treatment complaints or symptoms that involves a 
clinically significant change in severity or duration of symptoms, or requires 
clinical intervention that is different from ordinary postoperative care: i.e. 
temporary abdominal pain, regurgitation or vomiting associated with eating.  
 
Complications associated with anesthesia, cystoscopy of blood draw. 
 
An anticipated adverse event may be either serious or non-serious 
21.1.4 Serious adverse event (SAE) 
An SAE is an event that has led to any of the following: 
 
Led to death  
 
Led to a serious deterioration on the health of a subject that either resulted in: 
 
A life-threatening illness or injury, or 
 
A permanent impairment of body structure or body function, or 
 
in-patient hospitalization (hospital admission) greater than 24 hours or prolonged 
hospitalization 
 
medical or surgical intervention to prevent life-threatening illness, permanent 
impairment of body structure or body function 
 
Led to fetal distress, fetal death or congenital abnormality or birth defect. (ISO 
14155:21011(E)). 
21.1.5 Serious Adverse Device Effect (SADE):   
An SAE may be further characterized as a serious adverse device effect (SADE) if it is 
related to the use of the investigational device. 
21.1.6 Unanticipated Adverse Device Effects (UADE):   
UADE are defined as any serious adverse effect on health or safety or any life-
threatening problem, or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or application (including supplementary plan or application), or 

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any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects (21 CRF 812.39s).  
21.1.6.1 Unanticipated Serious Adverse Device Effect (USADE):  
A UADE may be further defined as a USADE if it is related to the use of the 
investigational device. 
21.1.7 Not Considered Adverse Events  
The following are not considered to be adverse events: 
 
Pre-existing Conditions: Any current condition that is recorded as a pre-
existing condition on a case report form is not considered an adverse event 
unless there is a worsening of that condition in terms of nature, severity, or 
degree of incidence.   
21.2 AE Assessment, Documentation and Reporting 
Complete an Adverse Event eCRF.  Provide a complete description of the nature, 
severity and circumstances of the Adverse Event including results of physical 
examinations, diagnostic tests, treatments given, outcome of treatments and the 
subject’s final condition.   
Reports to the Sponsor. 
Report all Serious Adverse Events, and Unanticipated Adverse Device Events to the 
Sponsor as soon as adequate information about the adverse event is available, but no 
later than 5 working days from the date the Investigator first became aware of the event.  
Notify the Sponsor by completing, or partially completing, Adverse Event eCRF.   
Reports to the IRB. 
Investigators are required to report all Unanticipated Adverse Device Events (See 21.3 
for definition) to the reviewing IRB no later than 10 working days from the date that the 
Investigator first became aware of the event.  In addition, the Investigator must comply 
with any other reporting requirements of the reviewing IRB. 
21.3 Reporting Device Deficiencies. 
If a device deficiency is suspected, The Spanner should be evaluated to determine if 
removal or replacement is necessary.  All device deficiencies related to the identity, 
quality, durability, reliability, safety or performance of an investigational medical device 
shall be documented throughout the clinical investigation and appropriately managed by 
the sponsor.  All Device Deficiencies, whether resulting in a symptom or not, should be 
reported as an Adverse Event and an Adverse Event eCRF should be completed. 
 
21.4 Foreseeable Device Deficiencies/Malfunctions 
List is provided in Section 7 of this CIP, Anticipated Device Deficiencies. 
21.5 Managing Adverse Events and Device Deficiencies 

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The following guidelines are recommended for managing Adverse Events and 
complications that may occur during the study.  As these are only guidelines, the final 
decision for appropriate management of Adverse Events rests on the investigator’s 
clinical judgment. Contact the SRS Medical for additional guidance on a case-by-case 
basis. 
 
If a device deficiency is known or suspected, The Spanner should be evaluated 
to determine if removal is necessary.   
 
If a device is removed in either in association with an adverse event or a device 
deficiency, then the subject is to attend the next scheduled visit.   
 
If the subject has no unresolved adverse events, then the subject should 
complete the study visit, including replacement of the stent and resume the study 
visit schedule.   
 
If the subject has unresolved adverse events, then complete as much of the 
study visit as possible, but do not place the stent.  The subject should resume the 
study schedule and be reassessed at the next visit for the possibility of stent 
placement. 
21.5.1 Bacteriuria 
Bacteriuria will be considered as present if the urine culture indicates a single organism 
with a colony count >100,000 CFU and the subject is asymptomatic. 
No treatment is required for asymptomatic bacteriuria and the subject may continue in 
the trial.  Only the initial occurrence of bacteriuria should be reported on the Adverse 
Event eCRF. If the event persists with the same organism to the next visit, it would still 
be considered the same event.  If bacteriuria with a new organism is present at a 
subsequent visit, it would be classified as a new event.  If the bacteriuria converted to a 
symptomatic urinary tract infection, it would also be considered a new event (see below). 
21.5.2 Symptomatic Urinary Tract Infection 
The criterion below will be used to determine if a subject has a symptomatic UTI. The 
criterion is based on a publication from the Center for Disease Control4.   
Symptomatic UTIs should be treated by the physician. If the physician determines that 
The Spanner should be removed as part of the treatment of a symptomatic UTI, the 
subject should continue in the study and attend the next study visit.  Spanner devices 
removed for symptomatic UTIs need not be returned to the Sponsor. 
Criterion for a symptomatic UTI:  
Subject has at least one of the following signs or symptoms:  
 
• fever (>38°C)  
 
• suprapubic tenderness*  
 
• costovertebral angle pain or tenderness*  
                                               
4 Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and Non-Catheter-
Associated Urinary Tract Infection [UTI]) and Other Urinary System Infection [USI]) Events, 
January 2015 

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 
• urinary frequency*  
 
• urinary urgency*  
 
• dysuria*  
AND,  
Subject has a urine culture with no more than two species of organisms, at least one of 
which is a bacteria of ≥100,000 CFU/ml.  
On a stent removal visit, if a subject has one of the above signs or symptoms and a 
positive urinalysis on that visit, the removal of stent is postponed as follows: 
 
Urine sample sent for Urine Culture and Sensitivity (as scheduled) 
 
The Subject will be scheduled for a follow-up visit to remove or replace the stent 
at a minimum of 72 hours after the initiation of treatment of the UTI. 
 
*With no other recognized cause  
21.5.3 Hematuria 
Transient gross hematuria from the trauma of The Spanner insertion may occur during 
the follow up period.  If this occurs, Spanner removal is not required but the incident 
should be reported as an Adverse Event.  
If persistent gross hematuria or an event with significant frank bloody urine occurs in the 
follow up period, The Spanner should be removed.  Cystoscopy should be performed as 
soon as possible and practical after removal of The Spanner to determine the source of 
bleeding and whether or not it is related to use of The Spanner.  An Adverse Event 
should be recorded and the device returned to the Sponsor.  The subject should 
continue in the study and attend the next study visit.   
21.5.4 Pain or Perceived Bladder or Urethral Spasm 
Severe pain. If a study subject experiences persistent severe pain believed to be related 
to The Spanner, it should be removed.  Following removal of The Spanner, a cystoscopy 
should be performed as soon as possible and practical to determine whether trauma or 
injury to the urethra, bladder or bladder neck is the probable source of the pain.  An 
Adverse Event should be recorded and the device returned to the Sponsor. The subject 
should continue in the study and attend the next study visit. 
Moderate-mild pain or discomfort, perceived bladder or urethral spasm.  The 
decision to remove The Spanner is left to the discretion of the subject and investigator.  
An Adverse Event should be recorded.  If the device is removed due to the symptoms, it 
must be returned to the Sponsor.  Note: If the device is removed, the subject should 
continue in the study and attend the next study visit.   
21.5.5 Meatal Irritation and Discomfort 
Meatal Irritation.  Irritation is defined as an inflammatory response at the meatus.  The 
decision to remove The Spanner is left to the discretion of the subject and investigator.  

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An Adverse Event should be recorded.  If the device is removed due to the symptoms, it 
must be returned to the Sponsor.  Note: If the device is removed, the subject should 
continue in the study and attend the next study visit.   
Meatal Discomfort.  The decision to remove The Spanner is left to the discretion of the 
subject and investigator.  An Adverse Event should be recorded.  If the device is 
removed due to the symptoms, it must be returned to the Sponsor.  Note: If the device is 
removed, the subject should continue in the study and attend the next study visit.   
21.5.6 Migration or Expulsion of the Device 
Migration- If migration of the Spanner is suspected, perform an x-ray or cystoscopy, if 
possible, to document the location of the device prior to attempting removal.   
Subsequently, the device should be removed, either by locating and grasping the 
retrieval suture to remove the device or, if the retrieval suture cannot be located, by 
retrieving the device cystoscopically.  In either case, care should be taken to assure that 
the proximal balloon is deflated prior to withdrawing the device through the urethra and 
that all of the device components are removed. (If possible, the balloon may be deflated 
by cystoscopically locating the suture that is attached to the proximal balloon and pulling 
it to remove the balloon drain plug to allow the balloon to empty. Alternately, the balloon 
may be ruptured cystoscopically using a cautery tool or wire guide.)   
Record a Device Deficiency eCRF and return the device to the Sponsor. Provide a 
detailed description of any damage to the device that is known to have occurred as a 
result of removing the device (i.e. balloon punctured, suture between stent and distal 
anchor cut).   
The subject should continue in the study and attend the next study visit.   
Expulsion - Record a Device Deficiency eCRF and return the device to the Sponsor. 
Provide a detailed description of any damage to the device that is known to have 
occurred as a result of removing the device (i.e. balloon punctured, suture between stent 
and distal anchor cut).  The subject should continue in the study and attend the next 
study visit.   
Urinary Retention- If urinary retention occurs, and there is a question of whether the 
retention is related to bladder performance, an urodynamic evaluation should be 
considered to determine if bladder performance is contributing to urinary retention.    
For urinary retention in a subject, cystoscopy or an x-ray should be performed prior to 
removal of The Spanner to verify whether device migration or inadequate stenting is the 
cause of the urinary retention.  Subsequently, the device should be removed. After 
Spanner removal, the subject should be evaluated to determine voiding capability and 
urinary catheter bladder drainage instituted if needed.   
An Adverse Event should be recorded and the device returned to the Sponsor.  The 
subject should continue in the study and attend the next study visit.   

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21.5.7 Occlusion of the Device Drainage Lumen or Device Malfunction 
If occlusion or malfunction of the device is suspected, The Spanner should be removed.  
A Device Deficiency eCRF should be completed and the device returned to the Sponsor.  
The subject should continue in the study and attend the next study visit.   
21.5.8 Criteria for Spanner Removal and Re-establishment of Bladder Drainage: 
Clinically Significant Post Void Residual Urine 
For purposes of the clinical trial, PVR > 350 ml on two measurements taken within a few 
hours will be considered as significant and requiring intervention.  If the subject has a 
PVR > 350 ml on two measurements taken within a few hours at any scheduled or visit, 
or at other medical visit, the intervention should include the removal of The Spanner, the 
re-establishment of bladder drainage (CIC or Foley) and the premature withdrawal of the 
subject from the study. 
21.6 Emergency Sponsor Contact Information for Reporting SAE and SADE 
Lee Brody 
SRS Medical 
Telephone: (978) 932-0400 / (617) 308-4056 [24 hours] 
Email: brody@srsmedical.com 
21.7 Data Monitoring Committee, 
A Data Monitoring Committee has not been established. 
22 VULNERABLE POPULATION 
This study will not recruit nor enroll subjects from vulnerable populations nor under 
emergency conditions. 
23 SUSPENSION OR PREMATURE TERMINATION OF THE 
CLINICAL INVESTIGATION 
23.1 Procedure for Suspension or Premature Termination 
The sponsor may suspend or prematurely terminate either a clinical investigation in an 
individual investigation site or the entire clinical investigation for significant and 
documented reasons. A principal investigator, IRB, or regulatory authority may suspend 
or prematurely terminate participation in a clinical investigation at the investigation sites 
for which they are responsible. If suspicion of an unacceptable risk to subjects arises 
during the clinical investigation, or when so instructed by the IRB or regulatory 
authorities, the sponsor shall suspend the clinical investigation while the risk is 
assessed. The sponsor shall terminate the clinical investigation if an unacceptable risk is 
confirmed. 
The sponsor shall consider terminating or suspending the participation of a particular 
investigation site or investigator in the clinical investigation if monitoring or auditing 
identifies serious or repeated deviations on the part of an investigator. 

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If suspension or premature termination occurs, the sponsor shall justify its decision in 
writing and promptly inform the other parties with whom they are in direct 
communication. The principal investigator and sponsor shall keep each other informed of 
any communication received from either the IRB or the regulatory authority. 
If, for any reason, the sponsor suspends or prematurely terminates the investigation at 
an individual investigation site, the sponsor shall inform the responsible regulatory 
authority as appropriate and ensure that the IRB is notified, either by the principal 
investigator or by the sponsor. If the suspension or premature termination was in the 
interest of safety, the sponsor shall inform all other principal investigators. 
If suspension or premature termination occurs, 
a) the sponsor shall remain responsible for providing resources to fulfil the 
obligations from the CIP and existing agreements for following up the subjects 
enrolled in the clinical investigation, and 
b) the principal investigator or authorized designee shall promptly inform the 
enrolled subjects at his/her investigation site, if appropriate. The method and the 
timing of this communication will depend on the circumstances and the perceived 
risks. All subjects must have the device removed and attend a 1 month follow-up 
visit.  
c) the study is not blinded so there need not be criteria for breaking the blind. 
23.2 Procedure for Resuming the Clinical Investigation After Temporary 
Suspension 
When the sponsor concludes an analysis of the reason(s) for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary 
suspension, the sponsor shall inform the principal investigators, the IRBs, and, where 
appropriate, the regulatory authority of the rationale and provide them with the relevant 
data supporting this decision. 
Concurrence shall be obtained from the IRBs and, where appropriate, regulatory 
authorities before the clinical investigation resumes. If subjects have been informed of 
the suspension, the principal investigator or authorized designee shall inform them of the 
reasons for resumption. 
24 PUBLICATION POLICY 
24.1 Confidentiality Agreement 
All goods, materials, information (oral or written) and unpublished documentation 
provided to the investigators, inclusive of this protocol and the case report forms are the 
exclusive property of SRS Medical. They may not be given or disclosed by the 
Investigator or by any person within his authority either in part or in totality to any 
unauthorized person without the prior written formal consent of SRS Medical. 

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24.2 Subject Confidentiality 
The investigators and sponsor commit to maintaining the confidentiality of individual data 
of subjects involved in the study.  All case report forms and related documents will be 
submitted using unique, confidential numbers assigned by SRS Medical and the site.  All 
documents submitted to SRS Medical should be maintained by the investigator in strict 
confidence. 
Each subject’s data will be completely de-identified in the final reports and subsequent 
publications. 
24.3 Ownership of Data and Use of Study Results 
All clinical data gathered during the study will be pooled in a common database that is 
the property of SRS Medical.  The results of the clinical study may not be published or 
presented at scientific meetings without the written approval of SRS Medical.  
24.4 Publication Policy 
At this time no publication or presentation is planned however the study will be published 
upon completion.  At that time each investigator must agree that no publications or 
abstracts will be submitted that will jeopardize a multi-center publication.  However, 
investigators may submit a request to SRS Medical to publish their single center 
experience if desired.   
The investigator agrees to inform the sponsor in writing and to submit all manuscripts at 
least 30-45 days prior to submission and abstracts at least seven days prior to 
submission. This allows the sponsor to protect proprietary information and to provide 
comments and give its approval prior to any submission of data, abstracts or 
manuscripts. Also, this assures that the sponsor has submitted the supplement pre-
market approval application, if it requires certain confidentiality of data before its 
publication. 
24.5 Clinical Trial Registration 
This study will be submitted for inclusion in the clinical trial registry at 
http://www.ClinicalTrials.gov.   
In accordance with the national regulations, the intent to carry out a clinical investigation, 
as well as the results thereof, will be made available. 
25 INSTITITIONAL REVIEW BOARD (IRB) 
25.1 IRB Approval 
The protocol and the informed consent document must have the initial and annual 
approval, as required by each IRB.  The signed approval letter must identify the 
documents approved (i.e., list the investigator's name, the protocol number and title, the 
date of the protocol and informed consent document, and the date of approval of the 
protocol and the informed consent document).  Any written information to be provided to 
the subject (e.g., subject education materials and/or subject information packet) and any 
advertisement used to recruit subjects must also be reviewed by the IRB.  The sponsor 

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will not ship clinical supplies until a signed approval letter from the IRB has been 
received and a contractual agreement has been signed by the sponsor and the clinical 
site.  
25.2 Continuing Communication with the IRB 
The following information shall be provided to the IRB in accordance with their 
requirements: 
 
serious adverse events, 
 
requests for deviations, and reports of deviations,  
 
progress reports, including safety summary and deviations, 
 
amendments to any documents already approved by the IRB;   
 
if applicable, notifications of suspensions or premature termination, 
 
if applicable, justification and request for resuming the clinical investigation after 
a suspension, 
 
clinical investigation report or its summary. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IRB prior to implementation: 
 
approval/favorable opinion of amendments,  
 
approval of the request for deviations that can affect the subject's rights, safety 
and well-being or the scientific integrity of the clinical investigation,  
 
approval for resumption of a suspended clinical investigation, if applicable. 
26 INVESTIGATOR RESPONSIBILITIES 
The role of the principal investigator is to implement and manage the day-to-day conduct 
of the clinical investigation as well as protecting the rights, safety, and welfare of 
subjects.  An investigator must conduct the investigation in accordance with the signed 
agreement with SRS Medical, the investigational plan, ISO 14155 standard and other 
applicable country laws, including data protection laws, the latest version of the 
Declaration of Helsinki and any conditions of approval imposed by an IRB   
The principles of the Declaration of Helsinki have all been implemented in this study by 
means of a subject informed consent process, IRB approval, training on the study, 
preclinical testing, risk benefit assessment, etc. 
26.1 Qualification of the Principal Investigator 
The principal investigator shall: 
a) be qualified by education, training and experience to assume responsibility for 
the proper conduct of the clinical investigation in accordance with this 
International Standard; evidence of such qualifications of the principal 
investigator and key members of the investigation site team shall be provided to 
the sponsor through up-to-date CVs or other relevant documentation, 
b) be experienced in the field of application and trained in the use of the 
investigational device under consideration, 

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c) disclose potential conflicts of interest, including financial, that interfere with the 
conduct of the clinical investigation or interpretation of results, and 
d) be knowledgeable with the method of obtaining informed consent. 
26.2 Qualification of investigation site 
The principal investigator shall be able to demonstrate that the proposed investigation 
site: 
a) has the required number of eligible subjects needed within the agreed 
recruitment period, and 
b) has one or more qualified investigators, a qualified investigation site team and 
adequate facilities for the foreseen duration of the clinical investigation. 
26.3 Study Agreement 
A Study Agreement shall be entered into effect by the PI [and/or investigational site] as 
per the local legal requirements, and returned to SRS Medical prior to the start of any 
study activities.  The PI indicates approval of the protocol and any amendments by 
signing and dating the agreement.  Amendments to the protocol shall be agreed upon 
between SRS Medical and the PI and be recorded with a justification of the 
amendments. 
26.4 Communication with the IRB 
The principal investigator shall: 
a) provide the sponsor with copies of any clinical-investigation-related 
communications between the principal investigator and the IRB, 
b) obtain the written and dated approval/favorable opinion of the IRB for the 
clinical investigation before recruiting subjects and implementing all subsequent 
amendments, if required, 
d) perform safety reporting, 
e) promptly report any deviations from the CIP that affect the rights, safety or 
well-being of the subject or the scientific integrity of the clinical investigation, 
including those which occur under emergency circumstances, if required by the 
IRB, CIP or national regulations. In particular circumstances, the communication 
with the IRB can be performed by the sponsor, partly or in full, in which case the 
sponsor shall keep the principal investigator informed. 
26.5 Informed Consent Process 
The principal investigator shall ensure compliance with the applicable regulatory 
requirements and ethical principles for the process of obtaining informed consent, and 
ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
26.6 Compliance with the CIP 
The principal investigator shall indicate his/her acceptance of the CIP in writing and 
conduct the clinical investigation in compliance with the CIP and propose to the sponsor 
any appropriate modification(s) of the CIP or investigational device or of the use of the 

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investigational device. He shall refrain from implementing any modifications to the CIP 
without agreement from the sponsor, IRB and regulatory authorities, if required, and 
document and explain any deviation from the approved CIP that occurred during the 
course of the clinical investigation. At the end of the study he will sign the clinical 
investigation report. 
The investigator is also responsible for ensuring that IRB approval of the protocol, 
informed consent and any other written information provided to the subject is in place 
before obtaining written consent from a subject.  This approval should be in the form of a 
letter and identify the version or date of the documents approved.  The approval letter 
should be accompanied by an IRB roster or letter of compliance to allow verification that 
the PI, other site study staff or SRS Medical personnel are members of the IRB.  If they 
are members of the IRB, written documentation is required stating that they did not 
participate in the approval process.  If the IRB imposes any additional requirements (e.g. 
safety reports, progress reports, etc.), SRS Medical will prepare the required documents 
and provide them to the PI for reporting to the IRB. The PI must inform SRS Medical of 
any change in status of IRB approval once the site has started enrollment in the study.  If 
any action is taken by an IRB with respect to the study, that information will be forwarded 
to SRS Medical by the PI. 
It is the responsibility of the Investigator to complete and maintain adequate and 
accurate eCRFs, which have been designed by the sponsor to record all observations 
and other pertinent data to the clinical investigation.  The investigator shall assure the 
accuracy, completeness, legibility and timeliness of the data reported to the sponsor on 
the CRFs and in all required reports. Where copies of the original source document as 
well as printouts of original electronic source documents are retained, these shall be 
signed and dated by a member of the investigation site team with a statement that it is a 
true reproduction of the original source document. Source documents shall be created 
and maintained by the investigation site team throughout the clinical investigation. 
Ensure that all clinical-investigation-related records are retained as specified and make 
them available as requested during monitoring visits or audits, Allow and support the 
sponsor to perform monitoring and auditing activities, be accessible to the monitor and 
respond to questions during monitoring visits, allow and support regulatory authorities 
and the IRB when performing auditing activities.   
In addition, the investigator shall only permit an investigational device to be used under 
his or her direct supervision only with subjects that are enrolled in the clinical study and 
shall not use an investigational device on any person not authorized to receive it. Use of 
the investigational device is to be used only in accordance with this Clinical 
Investigational Plan and instructions for use.  Upon SRS Medical request, study 
completion, or termination of this study (or the investigator’s part of the study), the 
investigator shall return to SRS Medical any remaining supply of the investigational 
device system. 
Upon request, the investigator shall disclose sufficient accurate financial information to 
SRS Medical, and promptly update this information if any relevant changes occur during 
the course of the study and for 1 year after study completion.  The PI should provide 
SRS Medical with a recently signed and dated curriculum vitae (CV) from all key 

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members of the investigational site study team as listed on the study delegation task list 
(dated within 3 years of the date of site activation). The sponsor will avoid improper 
influence on, or inducement of the subject, monitor and investigator or other parties 
participating in, or contributing to, the study by implementing the subject informed 
consent process, study agreements and IRB approval of the study. 
The investigator shall ensure that an adequate investigation site team and facilities exist 
and are maintained and documented during the clinical investigation. New members of 
the investigation site team may be added during the study. New personnel should only 
start their assignment after receiving adequate training in the clinical investigation 
requirements and this training shall be documented. The names, initials, signatures, 
functions, and designated authorizations of new personnel shall be documented. He 
shall ensure that maintenance and calibration of the equipment relevant for the 
assessment of the clinical investigation is appropriately performed and documented. 
26.7 Medical Care of Subjects 
The principal investigator shall: 
a) provide adequate medical care to a subject during and after a subject's 
participation in a clinical investigation in the case of adverse events,  
b) inform the subject of the nature and possible cause of any adverse events 
experienced, 
c) inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
d) provide the subject with well-defined procedures for possible emergency 
situations related to the clinical investigation, and make the necessary 
arrangements for emergency treatment,  
f) ensure that clinical records are clearly marked to indicate that the subject is 
enrolled in a particular clinical investigation, 
g) if appropriate, subjects enrolled in the clinical investigation shall be provided 
with some means of showing their participation in the clinical investigation, 
(contact address and telephone numbers shall be provided), 
h) inform, with the subject's approval or when required by national regulations, 
the subject's personal physician about the subject's participation in the clinical 
investigation, and 
i) make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's 
rights. 
26.8 Safety Reporting 
The principal investigator shall 
a) record every adverse event and observed device deficiency, together with an 
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b) report to the sponsor, without unjustified delay, all serious adverse events and 
device deficiencies that could have led to a serious adverse device effect; 
c) report to the IRB serious adverse events and device deficiencies that could 
have led to a serious adverse device effect, if required by the IRB, 
d) report to regulatory authorities serious adverse events and device deficiencies 
that could have led to a serious adverse device effect, as required by the national 
regulations, and 
e) supply the sponsor, upon sponsor's request, with any additional information 
related to the safety reporting of a particular event. 
27 RESPONSIBILITIES OF THE SPONSOR 
SRS Medical or designee(s) will perform the following: 
27.1 Clinical Quality Assurance and Quality Control 
Quality assurance and quality control principles shall apply to the processes of the 
clinical investigation. The sponsor shall implement and maintain written clinical quality 
procedures to ensure that the clinical investigation is designed, conducted and 
monitored, and that data are generated, documented, recorded and reported in 
compliance with this International Standard, the CIP, any subsequent amendment(s), 
and any other applicable standards and regulatory requirements.   
They shall maintain records to document the compliance of all parties involved in the 
clinical investigation, ensure that the auditing requirements are met, if applicable, and 
justify and document significant exceptions to the requirements of the International 
Standards. 
Clinical quality assurance and quality control may be integrated in the sponsor's overall 
quality system. 
27.2 Clinical Investigation Planning and Conduct 
Prior to commencement of the clinical investigation, the sponsor shall: 
a) define, establish and allocate all the roles and responsibilities related to the 
clinical investigation in one or more written agreements,  
b) select appropriately qualified principal investigators,  
c) receive disclosures of conflict of interest from principal investigators and 
investigators, where required by national regulations, 
e) ensure the members of the investigation site team and their designated 
authorization(s) are identified in a log with delegated responsibilities detailed,  
f) designate or appoint one or more monitors, or otherwise assume the 
responsibilities of the monitor(s),and  
g) ensure documentation of training, experience and scientific or clinical 
knowledge for all the relevant parties involved in order to adequately conduct the 
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 
the use of the investigational device(s), 
 
device accountability procedures , 
 
CIP, 
 
eCRFs and instructions for completion, 
 
the written informed consent form and process as well as other written 
information provided to subjects, and 
 
sponsor's written procedures, International Standards and any applicable 
regulatory requirements; 
h) ensure that, in multicenter investigations, all investigators and all other parties 
involved are given instructions on uniformly assessing and documenting clinical 
and laboratory findings, 
i) ensure that any clinical-investigation-related activities of sponsor 
representative(s) at the investigation site(s) are described in the CIP and the 
informed consent form, and that these activities occur in such a way that they do 
not bias the data integrity,. 
27.3 Preparation of Documents and Materials 
Prior to commencement of the clinical investigation, the sponsor shall: 
a) prepare contacts and essential documents and ensure they are approved by 
the relevant persons by dated signature. 
b) assure the accuracy of translations, where relevant, 
c) ensure that a supply of investigational devices is available in a timely manner 
for the clinical investigation.  Investigational devices shall not be made available 
to the principal investigator until all requirements to start the clinical investigation 
are met, 
d) provide a clinical liability insurance,  
e) document any financial arrangements between the principal investigator or the 
investigation site and the sponsor, 
f) submit any required application(s) to begin the clinical investigation in a given 
country to the appropriate regulatory authorities for review, acceptance or 
permission.  
g) ensure that IRB's approval/favorable opinion is obtained and documented, and 
that appropriate provisions are made to meet any conditions imposed by the IRB, 
and 
h) ensure that any modification(s) required by the IRB or regulatory authority are 
made and documented by the principal investigator and have gained the 
approval/favorable opinion of the IRB or regulatory authority. 
27.4 Conduct of the Clinical Investigation 
The sponsor shall be responsible for: 
a) accountability of investigational devices throughout the clinical investigation, 

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b) documenting correspondence with all parties involved in the clinical 
investigation, including IRBs and regulatory authorities, 
c) ensuring that the clinical investigation is appropriately monitored by 
determining the extent and nature of monitoring, including the strategy for source 
data verification, based on considerations such as the objective, design, 
complexity, size, critical data points and endpoints of the clinical investigation, 
d) reviewing the monitoring reports and following up any actions required in the 
monitoring reports,  
e) taking prompt action to secure compliance with all clinical investigation 
requirements, and 
f) submitting progress reports, including safety summary and deviations, when 
requested, to all reviewing IRBs and the regulatory authorities. 
27.5 Monitoring 
The purpose of clinical investigation monitoring is to verify that the conduct of the clinical 
investigation complies with the approved CIP, subsequent amendment(s), the FDA and 
International Standards, and the applicable regulatory requirement(s). Monitoring 
activities may be conducted by the Monitor or the Sponsor. 
27.5.1 Qualifications of the Monitor 
Monitors shall be: 
a) qualified in the field of the International Standards through training and 
experience as well as scientific or clinical knowledge; 
b) knowledgeable on the use of the investigational device(s) and relevant 
requirements, CIP and informed consent process  
c) trained on the sponsor's clinical quality assurance and quality control system 
as well as any special procedures for monitoring a specific clinical investigation. 
Training shall be documented in the sponsor's files. 
27.5.2 Assessment of the Investigation Site 
The monitor shall assess each investigation site to verify that the principal investigator 
has: 
a) adequate qualifications; 
b) adequate resources, including facilities, laboratories, equipment and a 
qualified investigation site team; 
c) access to an adequate number of subjects. 
27.5.3 Initiation of the Investigation Site 
The monitor shall initiate each investigation site to ensure that the principal investigator 
and investigation site team: 
a) have received and understood the requirements and contents of: 

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 
CIP, 
 
IRB, 
 
the informed consent form, 
 
eCRFs, 
 
the instructions for use, 
 
any written clinical investigation agreements, as appropriate, 
b) have access to an adequate number of investigational devices, 
c) have been trained in the use of the investigational device, and 
d) are familiar with the responsibilities of the principal investigator. 
27.5.4 Interim Monitoring Visits On-site  
The monitor shall perform interim on-site monitoring visits to verify that: 
a) compliance with the CIP, any subsequent amendment(s), this International 
Standard and regulatory requirements is maintained; deviations shall be 
discussed with the principal investigator(s) or authorized designee, documented 
and reported to the sponsor, 
b) only authorized individuals are participating in the clinical investigation, 
c) the investigational device is being used according to the CIP or instructions for 
use and that, where modifications are required to the device, its method of use or 
the CIP, these are reported to the sponsor, 
d) investigation site resources, including laboratories, equipment and the 
investigation site team, remain adequate throughout the duration of the clinical 
investigation, 
e) the principal investigator continues to have access to an adequate number of 
subjects and investigational devices, 
f) signed and dated informed consent forms have been obtained from each 
subject at the point of enrollment or before any clinical-investigation-related 
procedures are undertaken, 
g) source documents and other clinical investigation records are accurate, 
complete, up to date, stored and maintained appropriately, 
h) eCRFs and queries are complete, recorded in a timely manner, and consistent 
with source documents, 
i) appropriate corrections, additions or deletions are made to the eCRFs, dated, 
explained if necessary and initialed by the principal investigator or by his/her 
authorized designee; the monitor shall not make corrections, additions or 
deletions to the eCRFs, 
j) all adverse events and device deficiencies are reported to the sponsor, and all 
serious adverse events and device deficiencies that could have led to a serious 
adverse device effect are reported to the sponsor without unjustified delay, 
k) all serious adverse events and deviations are reported to the IRB, if required, 

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m) all other required reports, notifications, applications, submissions and 
correspondence are maintained in the investigator's files and are accurate, 
complete, timely, legible, dated and identify the clinical investigation, 
o) current laboratory normal values, laboratory certifications, accreditations, or 
other validations are present in the investigator's file, if required, 
p) subject withdrawal has been documented; the monitor shall discuss this with 
the principal investigator or his/her authorized designee, 
q) subject non-compliance with the requirements stated in the informed consent 
has been documented; the monitor shall discuss this with the principal 
investigator or his/her authorized designee,  
r) the principal investigator and investigation site team are informed and 
knowledgeable of all relevant document updates concerning the clinical 
investigation, and 
s) any corrective and preventive actions, as needed, have been implemented 
and are effective. 
27.5.5 Close-out Activities 
The monitor shall perform close-out activities. 
27.5.6 Monitoring Reports 
All monitoring activities shall be documented in a written report to the sponsor and shall 
include: 
a) the date, investigation site identification, name of the monitor and name of the 
principal investigator or other individuals contacted, and 
b) a summary of what the monitor reviewed and his/her observation(s) with 
regard to the completion of previous action items, significant findings, facts, 
deviations, conclusions, and recommended actions to be taken to secure 
compliance. 
A copy of the monitoring report or a summary of key findings shall be shared with the 
principal investigator in writing. 
27.6 Safety Evaluation and Reporting 
The sponsor is responsible for the classification of adverse events and ongoing safety 
evaluation of the clinical investigation and shall: 
a) review the investigator's assessment of all adverse events and determine and 
document in writing their seriousness and relationship to the investigational 
device; in case of disagreement between the sponsor and the principal 
investigator(s), the sponsor shall communicate both opinions to concerned 
parties,  
b) review all device deficiencies and determine and document in writing whether 
they could have led to a serious adverse device effect; in case of disagreement 

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between the sponsor and the principal investigator(s), the sponsor shall 
communicate both opinions to concerned parties, 
c) report or ensure the reporting, to the IRB by the principal investigator(s), of all 
serious adverse events and device deficiencies that could have led to a serious 
adverse device effect, if required by national regulations or by the IRB,  
d) report to regulatory authorities, within the required time period, all serious 
adverse events and device deficiencies that could have led to a serious adverse 
device effect, if required by national regulations, 
e) report all relevant safety information to the DSMB, if established, according to 
written procedures, 
f) in the case of a multicenter clinical investigation, inform all principal 
investigators in writing of all the serious adverse device effects at all investigation 
sites that have been reported to the sponsor, and ensure that they are reported 
to their EC, if required by national regulations or by the IRB, whichever is more 
stringent, 
g) ensure that the IRB and the regulatory authorities are informed of significant 
new information about the clinical investigation, and 
h) in case of serious adverse device effects and device deficiencies that could 
have led to serious adverse device effects, determine whether the risk analysis 
needs to be updated and assess whether corrective or preventive action is 
required. 
27.6.1 Clinical Investigation Close-out 
The sponsor shall: 
a) ensure all clinical investigation close-out activities are properly conducted, 
b) provide a statistical analysis of the data, 
c) produce a clinical investigation report and 
d) ensure that the clinical investigation report, whether for a completed or 
prematurely terminated clinical investigation, is provided to the EC, participating 
investigators and regulatory authorities, as required by national regulations. 
27.7 Outsourcing of Duties and Functions 
The sponsor may transfer any or all of the duties and functions related to the clinical 
investigation, including monitoring, to an external organization (such as a CRO or 
individual contractor), but the ultimate responsibility for the quality and integrity of the 
clinical investigation data shall reside with the sponsor. All requirements in the 
International Standards applying to a sponsor shall also apply to the external 
organization inasmuch as this organization assumes the clinical-investigation-related 
duties and functions of the sponsor. 
The sponsor shall specify in writing any clinical-investigation-related duty or function 
assumed by the external organization, retaining any clinical-investigation-related duties 
and functions not specifically transferred to, and assumed by, the external organization. 

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The sponsor shall be responsible for verifying the existence of and adherence to written 
procedures at the external organization. 
27.8 Communication With Regulatory Authorities 
The sponsor shall, if required: 
a) notify or obtain approval from regulatory authorities in the country where the 
clinical investigation is conducted, 
b) report on the progress and status of the clinical investigation, and 
c) perform safety reporting 

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28 BIBLIOGRAPHY 
1. Alastair Henderson, Robert W. Laing, Stephen E.M. Langley. Department of 
Urology, St. Luke’s Cancer Centre, Royal Surrey County Hospital, Guildford, 
GU2 5XX UK Department of Oncology, St. Luke’s Cancer Centre, Royal Surrey 
County Hospital, Guildford, GU2 5XX, UK. A Spanner™ in the works; the use of 
a new temporary urethral stent to relieve bladder outflow obstruction after 
prostate brachytherapy. © 2003 American Brachytherapy Society  
2. A.P. Corica, B.T. Larson, A. Sagaz, A.G. Corica and T.R. Larson: A novel 
temporary prostatic stent for the relief of prostatic urethral obstruction. 
Department of Urology, Universidad Nacional de Cuyo, Mendoza, Argentina, 
Institute of Medical Research, Scottsdale, Arizona, and Department of 
Microbiology and Molecular Cell Biology, Eastern Virginia Medical School, 
Norfolk, VA, USA. British Journal of Urology Volume 93, Issue 3, February 2004 
3. Neal D. Shore, Martin K. Dineen, Mark J. Saslawsky, Jeffrey H. Lumerman and 
Alberto P. Corica A Temporary Intraurethral Prostatic Stent Relieves Prostatic 
Obstruction Following Transurethral Microwave Thermotherapy From Grand 
Strand Urology (NDS), Myrtle Beach, South Carolina, Atlantic Urology Associates 
(MKD), Daytona Beach, Florida, Southeast Urology Network (MJS) Memphis, 
Tennessee, Urological Surgeons of Long Island (LHL), Garden City, New York, 
and Instituto Urologico De Guayama (APC), Guayama, Puerto Rico The Journal 
of Urology Vol. 77, 1040-1046, March 2007  
4. Samuel J.S. Grimsley, MRCS, M.H. Khan, MRCS, Elspeth Lennox, RGN, and 
Peter H. Paterson, FRCS (Urol) Experience with the Spanner Prostatic Stent in 
Subjects Unfit for Surgery: An Observational Study Journal of Endourology 
Volume 21, Number 9, September 2007 © Mary Ann Liebert, Inc. DOI: 
10.1089/end.2006.0254 
5. Martin K. Dineen, Neal D. Shore, Jeffrey H. Lumerman, Mark J. Saslawsky, and 
Alberto P. Corica Use of a Temporary Prostatic Stent After 
TransurethralMicrowave Thermotherapy Reduced Voiding Symptoms and Bother 
Without Exacerbating Irritative Symptoms UROLOGY Volume 71, Number 5, 
May 2008  
6. Neal D. Shore, Mirza M. Baig, Anthony L. Cantwell, Douglas O. Chinn, Luay P. 
Susan How to manage BOO with temporary prostatic stenting, Urology Times 
July 2009  
7. Douglas O. Chinn Stenting of the Urethra for the Treatment of Urinary 
Complications Related to Prostate Prostate Cancer Research Institute Insights 
Publication, November 2009, 8-11  
8. Mark D. Tyson, Kimberly J. Hurd, Rafael N. Nunez, Christopher E. Wolter, 
Mitchell R. Humphreys Temporary Prostatic Urethral Stenting as a Provocative 
Tool to Determine Surgical Eligibility in Complex Bladder Outlet Obstructed 
Subjects: Our Initial Experience Curr Urol 2012;6:82–86, DOI: 
10.1159/000343515  
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 68 of 76 
 
ATTACHMENT A:  DEVICE LABELING 
3007035  
Physician’s IFU for The Spanner and Surveyor 
3007026  
The Spanner Selector Card 
1007364-X  
Label, Spanner  
1007365-X  
Label, Surveyor  
 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 69 of 76 
ATTACHMENT B:  SPANNER STUDY PROCEDURE FOR 
UROFLOW TESTING 
 
REQUIREMENT FOR A VALID UROFLOW TEST 
Enrollment Period – Visits 1, 2, 3 and 4: 
Once the participant is consented in the study they will have two attempts within a few 
hours to obtain PVR of 150 ml or less.   
Subjects will be withdrawn from the study only if they have a PVR of 350 ml or more on 
both attempts. 
 
TEST ENVIRONMENT 
The test should be conducted in a quiet, non-rushed environment in a location that 
provides for subject comfort and privacy. 
 
EQUIPMENT SET UP 
Prior to testing, verify correct operation and maintenance of the uroflowmeter. Complete 
any calibration or equipment set up recommended by the equipment manufacturer. 
 
ORIENTATION OF THE SUBJECT TO UROFLOW TESTING 
To reduce the influence of the test equipment and test environment on subject 
performance during testing, subjects participating in the study should be given an 
orientation prior to their first uroflow test under the study protocol.  
The orientation should consist of instruction on how to void into the test equipment and a 
simulated use demonstration (i.e. pouring water into the test set up) to show the subject 
how to do the test and how the equipment operates (e.g. if any operation of the 
equipment, like printing, occurs during testing).  Any instructions or precautions related 
to the specific uroflow equipment that will help achieve a technically good test should be 
reviewed with the subject. 
 
SUBJECT TESTING 
 
Have the subject drink two to four 8 oz. glasses of water. 
Hand out the How to Perform a Voiding Test Sheet to the subject, asking him to review it 
prior to testing.  Copies for distribution to study participants are provided in the individual 
case report form notebooks. (See sample on following page.) 
 
Instruct him to return for testing when he has a full bladder and strong urge to void. 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 70 of 76 
 
RECORDING THE TEST RESULT  
Record the values from the uroflow printout where indicated on the eCRF. In addition, 
due to the limitations of the uroflow equipment to account for artifacts, the investigator’s 
manual reading of the uroflow graph is optional based on investigator discretion. Record 
the investigator reading on the eCRF with the corresponding machine values, which 
must include Qmax in ml/s. Label the report with the test date, subject initials and ID 
number. Place the uroflow test reports and graphs in the subject notebook.   
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 
 
SAMPLE OF STUDY PARTICIPANT HANDOUT 
How to Perform a Voiding Test 
For Study Participants 
 
The voiding test is very useful to your physician’s assessment of your voiding problems 
and it is an important test in the study. The way in which you perform the test influences 
its usefulness.  Here are some reminders of things “to do” and “not to do” to help get the 
best test result. 
 
1. Drink two to four large glasses of water 1-2 hours before testing to make sure that 
you have a full bladder for the test. 
 
2. Wait until your bladder feels full and you have a fairly strong urge to urinate before 
you report for testing. 
 
3. To void get into a comfortable, steady position in front of the test equipment.  Avoid 
bumping or jarring the test equipment during the test. 
 
4. When you perform the test, do your best to direct your urine stream into the center of 
the collecting container.  Do not direct your stream onto the sides of the collecting 
container.  
 
5. Take as long as you need to empty your bladder.  

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 71 of 76 
ATTACHMENT C:  CHARLSON WEIGHTED INDEX OF 
COMORBIDITY  
 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 72 of 76 
ATTACHMENT D:  STUDY SUBJECT MATERIALS 
 
1007335  
Subject Information Booklet for The Spanner 
1007336  
Subject Emergency Removal Card 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 73 of 76 
ATTACHMENT E:  CASE REPORT FORMS 
CRF01  
Case Report Form – Screening Visit 1 
CRF02  
Case Report Form – Spanner Insertion Visit 1 
CRF03  
Case Report Form – Stent #1 Removal & Stent #2 Placement Visit 2 
CRF04  
Case Report Form – Stent #2 Removal & Stent #3 Placement Visit 3 
CRF05  
Case Report Form – Stent #3 Removal Visit 4 
CRF06  
Case Report Form – Follow-up Interview 
CRF11  
Informed Consent 
CRF12  
IPSS Survey 
CRF13  
Subject Questionnaire 
CRF21  
Adverse Event Form 
CRF22  
Protocol Deviation Form 
CRF23  
Study Completion Form 
CRF24  
Unscheduled Visit Form 
CRF25  
Device Deficiency Form 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 74 of 76 
ATTACHMENT F:  MATERIALS IN CONTACT WITH TISSUES OR 
BODY FLUIDS 
 
Spanner Stent Materials and Route of Biocontact 
Material 
Grade/Formulation 
(where applicable) 
Where Used? 
Biocontact 
Silicone 
Rubber 
NuSil MED1-4213, NuSil MED2-
4213 
Silicone Adhesives 
Direct Tissue 
NuSil MED-4720 
Balloon  
Cover Slip  
Direct Tissue 
NuSil MED-4830 
Proximal Tube Assembly 
Distal Anchor Assembly  
Direct Tissue 
NuSil MED 4725/4735 blend, 
Parylene N coated 
Check Valve 
Indirect Tissue 
NuSil MED-4870/MED-4770 
Inner Sleeve 
Indirect Tissue 
Stainless 
Steel  
304, 304V 
Plug 
Distal Anchor Assembly 
Direct Tissue 
Epoxy  
USP Class VI 
Tra-Con , Inc., Tra-Bond FDA2 
Epoxy 
Direct Tissue 
Fluorosilicone 
Fluid 
NuSil Med 420 
Lubricant 
Direct Tissue 
Nylon 
Type 6/6 non-absorbable 
Device Suture 
Suture (black suture dyed with 
Hematein (logwood) black) 
Direct Tissue 
Polyester 
2/0 green surgical suture 
Access Tether (Shore Line) 
Direct Tissue 
 
Insertion Tool Materials and Route of Biocontact 
Material 
Grade/Formulation (where 
applicable) 
Where Used? 
Biocontact 
Silicone 
Rubber 
St Gobain Tygon 3350 Tubing 
Silicone Sleeve 
No Tissue 
Contact 
NuSil MED-4234 
Sealing Ring 
Direct Tissue 
GE Silicone LSR 4030 
Spacer Sleeve 
Direct Tissue 
NuSil MED1-4213, MED 2-4213 
Silicone Adhesive  
Direct Tissue 
Wacker Silicones R-4105/60 
Push Tube 
Direct Tissue 
NuSil MED 4970, Wacker 
Silicones ELR Plus 4105/70 
K20R 
Anchor Sleeve Subassembly 
Direct Tissue 
Stainless 
Steel / Metals 
304V 
Coil 
Needle Tip 
Anchor Sleeve Assembly 
Stiffener Wire 
Indirect Tissue 
Brass with Nickel Plating 
Needle Tip Luer Connector 
Indirect Tissue 
Polyurethane 
Dow Pellethane 2363-55DE, 30% 
BaSO4 
Inflation Tube 
Direct Tissue 
Polyurethane 
Colorant 
30% BaSO4, White 
White Colorant for Inflation Tube 
Direct Tissue 
Polycarbonate 
LEXAN 104-1111, USP Class VI 
Push Cup 
Direct Tissue 
Tube Barb 
Barrel Hand piece 
Indirect Tissue 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 75 of 76 
Insertion Tool Materials and Route of Biocontact 
Material 
Grade/Formulation (where 
applicable) 
Where Used? 
Biocontact 
Acetal 
Homopolymer 
21CFR 117.2490 or ASTM 4181, 
Class I, Grade I 
Plunger Stop 
No Tissue 
Contact 
Platinum 
Primer 
NuSil CF2-135 
Primer, Silicone 
Direct Tissue 
Epoxy 
USP Class VI 
Tra-Con , Inc., Tra-Bond FDA2 
Epoxy 
Direct Tissue 
Ink 
Nontoxic Permanent Marker 
(ASTM D4236) 
Push Cup 
Direct Tissue 
 
Surveyor Materials and Route of Biocontact 
Material  
Grade/Formulation (where 
applicable) 
Where Used? 
Biocontact 
Silicone 
Rubber 
NuSil MED1-4213, NuSil MED2-
4213 
Adhesive 
Direct Tissue 
GE LSR 4030 
Subassembly Proximal Tip 
NuSil MED-4720 
Balloon  
Stainless 
Steel 
304V 
Stiffener 
No Tissue 
Contact 
Ferrule 
Probe Wire 
Direct Tissue 
Polycarbonate 
LEXAN 104-1111, USP Class VI 
Probe Wire Handle 
Stopcock 
Wire Guide 
Indirect Tissue 
Stop 
Direct Tissue 
Platinum 
Primer 
NuSil CF2-135 
Primer, Silicone  
Direct Tissue 
High Density 
Polyethylene 
Lupolen 6021D 
Stopcock 
Indirect Tissue 
Epoxy 
USP Class VI 
Tra-Con , Inc., Tra-Bond FDA2 
Epoxy 
Direct Tissue 
Aliphatic 
Polyether-
based 
Polyurethane 
TecoFlex, EG-65D-B20 
Catheter Tubing (a.k.a. Inflation 
Tube) 
Direct Tissue 
Polyurethane 
Colorant 
20% BaSO4, White 
White Colorant for Catheter Tubing 
Direct Tissue 
PTFE (a.k.a. 
Teflon) 
USP Class VI or ASTM D1710, 
Type I Grade I, Class D 
Probe Tip 
Direct Tissue 
 
 

SRS Medical Systems, Inc. 
 
CONFIDENTIAL 
 
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder 
Drainage in Men Unfit for Other Treatments  
 
Rev. D 
 
 
Page 76 of 76 
ATTACHMENT G:  ABBBREVIATIONS 
AE – Adverse Event 
ADE – Adverse Device Effect  
BPH – Benign Prostatic Hyperplasia 
CIP – Clinical Investigation Plan 
DD – Device Deficiency 
DRE – Digital Rectal Examination 
DSMB – Data and Safety Monitoring Board  
EC – Ethics Committee 
eCRF – Electronic Case Report Forms 
CTCAE - Common Terminology Criteria for Adverse Events 
FMEA – Failure Mode Effects Analysis 
GCP – Good Clinical Practice  
ICF – Informed Consent Form 
IPSS – International Prostate Symptom Score 
PI – Principal Investigator 
PTFE - Polytetrafluoroethylene a.k.a. Teflon® 
PVR – Post Void Residual 
Qmax – Maximum Flow Rate 
RBC – Red Blood Count 
SAE – Serious Adverse Event  
SADE – Serious Adverse Device Effect 
UA – Urinalysis 
UC&S – Urine Culture and Sensitivity 
UADE – Unanticipated Adverse Device Effect 
USADE – Unanticipated Serious Adverse Device Effect 
WBC – White Blood Count