Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Phase: NA
Conditions: Treatment of Benign Prostatic Hyperplasia
Sponsor: Boston Scientific Corporation

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
 
Ablation efficacy of contact side firing fiber in predefined 
settings for treating BPH 
  
 
Clinical Study Protocol 
 
 
Study Device:  
Lumenis pulse P120H Holmium Laser System  
 
Study Number: 
LUM-SBU-VP-15-02 
 
Protocol Revision: B 
 
Protocol Date:  
April 2016 
 
 
 
Sponsor Name: 
Lumenis, Ltd. 
 
Sponsor Address:  6 Hakidma St. 
 
Yokneam 20692 
 
Israel 
 
 
 
 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
STATEMENT OF CONFIDENTIALITY 
The information contained herein is Confidential Information that remains the sole and exclusive 
property of Sponsor and is expressly subject to the terms and conditions of the Clinical Trial Agreement 
signed by both the Investigator and Sponsor 
 
Study Personnel 
Site 
Site Principal Investigator 
New York Methodist Hospital 
506 6th. Street, Brooklyn,  
NY 11215  
USA   
Dr. Ivan Grunberger 
Chief Division of Urology and Professor of 
Clinical Urology.  
 
Tel: (718) 780-5403     
email: ivg9002@nyp.org                 
 
Sponsor Contacts 
 
Shoham Arad, PhD 
Clinical Affairs Manager 
Phone No.:  +972-4-9599106 
Cell No.:  +972-52-6388087 
Fax No.:  +972-4-9599142 
shoham.arad@lumenis.com  
Lumenis Ltd. 
6 Hakidma St. 
Yokneam Industrial Park 
Israel 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
Study Synopsis 
Study Title 
Ablation efficacy of contact side firing fiber in predefined settings for treating 
BPH 
 
Protocol No: 
LUM-SBU-VP-15-02 
Device Name: 
Lumenis Pulse 120H Holmium Laser system 
Design 
Prospective, single arm, single center 
Planned Study period 
Initiation: January 2016 
Final Report: August 2016 
Objectives 
Primary: To explore Vaporization efficacy and safety when treating PBH with 
the contact side firing fiber with recommended settings  
Secondary: To demonstrate the usability of BPH treatment with the combined 
tools Xpeeda+ Pulse 120H 
 
Study population 
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and 
candidates for surgery 
Main Inclusion 
Criteria  
 
Subject will be older than 18 years of age 
 
Subject was diagnosed with enlarged prostate of ≥ 30 gr volume 
 
Subject is a candidate for surgery treatment 
 
Subject is willing and has signed the Informed Consent Form 
 
AUA score ≥ 12 
 
Qmax <15 mL/s 
Main Exclusion 
Criteria  
 
Need to perform concomitant procedure, other than prostate vaporization 
 
PVR > 300mL  
 
Current Urine retention and Pdet <40 cm H20 
 
Documented or suspected prostate cancer and / or bladder cancer 
 
Neurogenic bladder disorder  / neurogenic voiding dysfunction 
 
Urethral strictures 
 
Previous prostatic, bladder neck, or urethral surgery  
 
Known history of spinal cord injury 
 
Urogenital trauma 
 
Bladder neck stricture 
 
Evidence of urinary tract infection 
 
History of chronic prostatitis 
Investigational 
Treatment and study 
course 
Following enrollment, each subject will undergo a single treatment for ablation 
of the prostate. Following treatment subjects will be required to return for follow-
up visits at 1 and 3 months. 
Follow up sessions: 
 
Peri-procedure and day of discharge 
 
One month post-surgery 
 
3 months post-surgery  

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
Criteria for Evaluation 
(endpoints) 
Primary Endpoints: 
 
Efficacy 
 
Ablation time 
 
Ablation rate calculated as: Prostate volume measured using pre and 
post treatment (3 month) TRUS images/ procedure time 
 
Ablation efficacy calculated as: Prostate volume measured using pre 
and post treatment (3 month) TRUS/ energy used 
 
Safety: 
Intraoperative complications 
 
Complications according to Clavien scale 
 
Conversion to TURP to maintain hemostasis (procedure completed with 
laser) 
 
Conversion to TURP to complete procedure  
 
Capsule perforation 
 
Blood loss (blood transfusion, pre and post-operative hemoglobin and 
hematocrit) 
2. Perioperative complications 
 
Urinary Retention  
 
Haematuria 
 
Dysuria 
 
Infection 
 
Urge incontinence 
 
Stress incontinence 
 
Erectile Dysfunction (International Score as compared to baseline) 
 
Re-catheterization 
 
Readmission for secondary operation 
 
Secondary Endpoint: 
 
Usability: 
 
Visibility during procedure- subjective assessment 
 
No. of fibers used during procedure 
 
Catheterization time 
 
Hospital stay duration 
 
IPSS QOL (follow-up visits as compared to baseline) 
 
QMax ml/s (follow-up visits as compared to baseline) 
 
PVR (follow-up visits as compared to baseline) 
 
PSA (follow-up visits as compared to baseline) 
 
AUA (follow-up visits as compared to baseline) 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
Table of Contents 
1 
Introduction .............................................................................................................................. 7 
 
Background ................................................................................................................................ 7 
1.1 
Rationale for Evaluation ............................................................................................................. 8 
2 
Device Description ................................................................................................................... 8 
2.1 
Laser System – Lumenis Pulse P120H Holmium Laser .............................................................. 8 
2.2 
Fibers ......................................................................................................................................... 8 
3 
Study Design ............................................................................................................................ 8 
4 
Study Objectives ...................................................................................................................... 9 
4.1 
Primary....................................................................................................................................... 9 
4.2 
Secondary .................................................................................................................................. 9 
5 
Outcome Measures .................................................................................................................. 9 
 
Primary Endpoints: ..................................................................................................................... 9 
 
Secondary Endpoint: ................................................................................................................ 10 
6 
Patient Population .................................................................................................................. 10 
 
Source and Sample Size .......................................................................................................... 10 
 
Eligibility ................................................................................................................................... 10 
7 
Study Procedures .................................................................................................................. 11 
 
Study duration and timelines .................................................................................................... 11 
 
Study Measures ....................................................................................................................... 11 
 
Screening Procedures .............................................................................................................. 12 
 
Pre-treatment evaluation .......................................................................................................... 13 
 
BPH treatment pre-operative preparations  (according to hospital routine of care) ................... 13 
 
Procedure ................................................................................................................................ 13 
 
Follow - up Regimen ................................................................................................................ 14 
8 
Study Analysis Plan ............................................................................................................... 14 
 
Study Analysis .......................................................................................................................... 14 
 
Interim report ............................................................................................................................ 14 
9 
Adverse Events (AE) .............................................................................................................. 15 
 
Adverse Events Definitions....................................................................................................... 15 
 
Reporting ................................................................................................................................. 17 
 
Risk/ Benefit Analysis ............................................................................................................... 17 
10 
Administrative Procedures .................................................................................................... 18 
 
Investigator Selection ............................................................................................................... 18 
 
IRB / Ethical Committee Approval ............................................................................................ 18 
 
Informed Consent ..................................................................................................................... 18 
 
Subject Withdrawal/Dropouts ................................................................................................... 19 
 
Case Report Forms/Data Collection ......................................................................................... 19 
 
Required Documentation .......................................................................................................... 19 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
 
Subject’s Financial Compensation ............................................................................................ 20 
 
Device Use/Accountability ........................................................................................................ 20 
 
Training Requirements ............................................................................................................. 20 
 
Modification of Protocol ........................................................................................................ 20 
 
Data Retention/Archiving Data ............................................................................................. 20 
 
Site Monitoring ..................................................................................................................... 20 
 
Termination of Study ............................................................................................................ 21 
 
Reporting Requirements ....................................................................................................... 21 
11 
References .............................................................................................................................. 21 
12 
Abbreviations and Terms ...................................................................................................... 22 
13 
Appendices ............................................................................................................................. 23 
 
 
 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
1 Introduction 
 Background 
The Lumenis Holmium Laser System family has been used for more than a decade for many procedures 
and specialties requiring excision, incision, ablation, and vaporization of tissue. 
The holmium:yittrium–aluminum–garnet (Ho:YAG) laser, known as the holmium laser, is a very 
commonly used laser in urological surgery [1, Error! Reference source not found.]. Its wavelength 
f 2,120 nm is very near the absorption peak of water (1,910 nm). As a result, it can be used for soft tissue-
based applications as well as stone fragmentation. Since soft tissue is comprised primarily of water, the 
holmium laser energy is effective for excision, incision, ablation, and vaporization when in direct contact 
with soft tissue, and for coagulation when a few millimeters from soft tissue. If fired directly onto mucosa, 
the laser has an effective penetration depth of 300– 400 micron, thus limiting the collateral injury during 
tissue-based applications. Additionally, stones (both urinary and gastrointestinal) contain sufficient 
amount of water that can absorb laser energy leading to their fragmentation, thus facilitating their removal 
[Error! Reference source not found.]. 
Delivery of holmium laser energy to the target tissue is commonly performed by emitting the energy 
through flexible hard core fibers of varying diameters. The flexibility of the fibers enables reaching and 
treating areas that otherwise would have been hard or impossible to reach. Fibers used for soft tissue 
procedures deliver the laser energy to the desired location by either emitting the laser beam forward 
(end-fire) enabling excision or to the side (side-firing) used mainly for ablation of tissue.  
Benign Prostate Hyperplasia (BPH) endourologic surgery can be performed by either excision of the 
prostate tissue (Holmium Laser Enucleation of the Prostate – HoLEP) or ablation of the prostate tissue 
(Holmium Laser Ablation of the Prostate – HoLAP). During the HoLAP procedure, a channel is created 
within the prostatic fossa to relieve the patient of symptoms secondary to BPH. Side-firing fiber is used 
to systematically remove superficial layers of the prostate tissue until a cavity is formed. Depending on 
the prostate volume, this can be a time consuming procedure. 
Ablation efficiency during the HoLAP procedure is limited by the laser system output power, 
transmission loss and the effectiveness of the energy applied to the tissue. The current Lumenis Pules 
p120H can deliver up to 120W with commonly used energy per pulse of 2-3J at frequencies ranging 
from 60-30 Hz, accordingly. In order to increase the effective energy per pulse that affects the tissue, 
any water based interface gap between the fiber and the tissue should be reduced to a minimum. This 
enables maximum energy to be absorbed directly by the water content of the tissue, leading to ablation. 
Therefore, using the fiber in direct contact with the tissue during ablation is considered an advantage, 
particularly in procedures requiring high ablation rate, such as HoLAP.  
In order to increase the efficiency of the HoLAP procedures Lumenis has developed several side firing 
fibers that can be used in contact with the tissue to maximize the laser tissue effect and increase the 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
ablation efficiency of the holmium laser. Together with the powerful tool of the pulse p120H Lumenis 
offer an efficient and safe combination for HoLAP procedure  
This study is intended to quantify the ablation efficiency and the safety of the Xpeeda fiber together with 
defined settings of the pulse 120H. 
1.1 Rationale for Evaluation 
The Lumenis Pulse P120H enables a wide range of working parameters that include use of high 
frequency at low energy. The usage of predefined set of parameters for vaporization and coagulations 
may aid the physician in completing the procedure in a relative short period of time, investing less time 
and energy with no complications. The combination of side firing fiber together with the pulse 120H is 
expected to show an effective tool to treat BPH.   
2 Device Description 
2.1 Laser System – Lumenis Pulse P120H Holmium Laser 
The Lumenis Pulse P120H is a high pulsed solid-state laser used for Urology procedures, worldwide. 
Importantly, both intended use and indications for use claims as well as underlying laser technology are 
similar to the marketed product. The activated laser is based on a flash lamp excited, Ho:YAG rod. The 
Ho:YAG rod derived photons are guided into the attached delivery system fiber. The system delivers a 
second, low powered laser in the visible wavelength spectrum of 650nm that enables aiming the high, 
invisible laser energy to the desired location.  
2.2 Fibers 
Xpeeda side firing silica fibers are improved fibers used for laser procedures, to deliver laser energy 
from the system to the treatment site. The Xpeeda fibers deliver energy directly to the tissue, due to the 
ability to use it in contact with the tissue during the entire procedure. Xpeeda fibers were design to 
withstand the high power laser emission of the Lumenis Pulse120H. The Xpeeda fiber is single use, 
supplied ethylene oxide sterile. 
 
 
 
 
3 
Study Design 
This is a one arms, prospective, single center study. Subjects will undergo a single treatment for 
ablation of the prostate using the study device. Follow up visits are scheduled for the day of release 
Figure 1 – side firing Xpeeda fiber 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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Page 
 
 
 
Confidential 
from the hospital and at 1 and 3 months post procedure. Additional treatment sessions, if required, will 
be at the discretion of the investigator, as part of the site standard of practice. Additional sessions will 
not be included in this study. 
4 Study Objectives 
4.1 Primary 
To explore Vaporization efficacy and safety when treating PBH with the contact side firing fiber with 
recommended settings  
4.2 Secondary 
Demonstrate the usability of BPH treatment with the combined tools Xpeeda fiber+ Lumenis Pulse 
120H system 
5 Outcome Measures 
 Primary Endpoints: 
5.1.1 
Efficacy 
 
Ablation time 
 
Ablation rate calculated as: Prostate volume measured using pre and post treatment (3 month) 
TRUS / procedure time 
 
Ablation efficacy calculated as: Prostate volume measured using pretreatment and post 
treatment (3 month) TRUS / energy used 
5.1.2 
Safety: 
5.1.2.1 Intraoperative complications 
 
Complications according to Clavien scale 
 
Conversion to TURP to maintain hemostasis (procedure completed with laser) 
 
Conversion to TURP to complete procedure  
 
Capsule perforation 
 
Blood loss (blood transfusion, pre and post-operative hemoglobin and hematocrit) 
5.1.2.2 2. Perioperative complications 
 
Urinary Retention  
 
Haematuria 
 
Dysuria 
 
Infection 
 
Urge incontinence 
 
Stress incontinence 
 
Erectile Dysfunction (International Score as compared to baseline) 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
 
Re-catheterization 
 
Readmission for secondary operation 
 Secondary Endpoint: 
5.2.1 
Usability: 
 
Visibility during procedure 
 
No. of fibers used during procedure 
 
Catheterization time 
 
Hospital stay duration 
 
IPSS QOL (follow-up visits as compared to baseline) 
 
QMax ml/s (follow-up visits as compared to baseline) 
 
PVR (follow-up visits as compared to baseline) 
 
PSA (follow-up visits as compared to baseline) 
 
AUA score (follow-up visits as compared to baseline) 
6 Patient Population 
 Source and Sample Size 
Subjects shall be selected by the physician within his patient population. One (1) site will participate in 
this study and will treat twenty (20) subjects. Enrolled subjects that did not complete the full course of 
the study will be discarded from performance analysis if they have not returned for the 1 and/or 3 month 
follow-up visits. 
 Eligibility 
Each subject will be evaluated by the Investigator to assess his suitability for entry into this study 
according to the following criteria:  
6.2.1 
Inclusion Criteria 
 
Subject will be older than 18 years of age 
 
Subject was diagnosed with enlarged prostate of ≥ 30 gr volume 
 
Subject is a candidate for surgery treatment 
 
Subject is willing and has signed the Informed Consent Form 
 
AUA score ≥ 12 
 
Qmax <15 mL/s 
Any of the following will exclude the subject from the study:  
6.2.2 
Exclusion Criteria  
 
Need to perform concomitant procedure, other than prostate vaporization 
 
PVR > 300mL  
 
Current Urine retention and Pdet <40 cm H20 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
 
Documented or suspected prostate cancer and / or bladder cancer 
 
Neurogenic bladder disorder  / neurogenic voiding dysfunction 
 
Urethral strictures 
 
Previous prostatic, bladder neck, or urethral surgery  
 
Known history of spinal cord injury 
 
Urogenital trauma 
 
Bladder neck stricture 
 
Evidence of urinary tract infection 
 
History of chronic prostatitis 
 
7 Study Procedures 
 Study duration and timelines 
For each subject the duration of the study will be of 3 months. Subjects may remain hospitalized 
following surgery, based on physician’s discretion. Subjects will be followed at the day of their 
discharge from the hospital. Each subject will return for follow-up visits at 1 and 3 months following the 
treatment procedure at which time they will have completed their participation in the study. 
It is expected that enrollment of all study subjects at the site will occur within 12-16 weeks from study 
initiation. 
 Study Measures 
7.2.1.1 Various assessments will be performed throughout the study at different time-points 
as detailed in fiber positioning, vaporization control and ability to successfully 
complete the procedure.  
Table 1. 
7.2.2 
Objective Measures 
7.2.2.1 Blood workup: including CBC, BMP, & PSA 
7.2.2.2 Urine workup: including urine analysis, and urine culture if applicable 
7.2.2.3 BPH volume will be performed using trans-rectal ultrasound prior to the procedure.  
All imaging verifying the diagnosis, pre-intervention images, intra-operative (during laser 
activation) images, immediate post-operative and follow-up images will be recorded on 
electronic media for documentation, further analysis and data recording. 
Subject anonymity will be assured for all images by deleting any ID detail. Only the code for 
the Case Number in the study will appear on the records being transferred to the sponsor.  
7.2.2.4 BPH treatment will be confirmed and three months post discharge using trans 
rectal ultrasound.  
7.2.2.5 Investigator Subjective Assessments 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
7.2.2.6 Procedure Questionnaire will record subjective usability parameters including 
visibility impairment and resolution (due to bleeding or other disturbances), fiber 
positioning, vaporization control and ability to successfully complete the procedure.  
Table 1 – Assessments time-points:  
Assessment 
 
Performed During Visit 
Baseline  
(Pre-
operative) 
 
Perioperative Hospital  
discharge 
1 
month 
follow-
up 
3 
month 
follow-
up 
Subject assessment  
(ICF, medical history, 
demographics, 
inclusion/exclusion 
evaluation) 
X 
 
 
 
 
 
 
Trans Rectal Ultrasound 
X 
 
 
 
X 
Post Void Residual 
Ultrasound 
X 
 
 
X 
X 
Q-Max Uroflow 
X 
 
 
X 
X 
Urodynamic Evaluation 
X 
 
 
 
 
Blood analysis 
(CBC, BMP & PSA) & urine 
analysis 
X 
X (CBC) 
 
 
X 
Urine culture (if applicable) 
X 
 
 
 
X 
Erectile Dysfunction 
X 
 
 
 
X 
Subject Questionnaires 
(AUA, QoL) 
X 
 
 
X 
X 
Physician Subjective 
Procedure Questionnaire 
 
 
X 
 
 
 
Adverse Event Assessment 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Screening Procedures 
7.3.1 
Subject Enrollment  

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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1. During the first visit, the investigator will screen the subject for eligibility to participate in the clinical 
study using the Inclusion & Exclusion criteria. During screening, the study physician will review the 
subject's medical history to ensure that the subject meets the study criteria.  
2. If the subject has met the preliminary study eligibility criteria, the study physician will obtain an 
informed consent from the subject, clearly indicating his/her understanding of the procedure, 
requirements and risks involved with study participation and other applicable treatment options.  
It will be understood that no compensation will be payed to the subjects for participating in the 
clinical study. 
3. The subject will be enrolled to the study and the treatment will be scheduled. 
 
7.3.2 
Subject Identification 
At enrollment, each subject will receive an identifying number that will include a consecutive serial 
number. The subject identification number and the subject initials will be used to identify the subject 
during the entire study and will be entered in the subject's CRF for each treatment.   
 Pre-treatment evaluation 
The following examinations are included in the standard of practice for subjects with PBH and may 
have been performed prior to the subject enrollment. Medical history as well as measurements that 
were completed prior to study enrollment will be used as baseline data for the study. 
A complete history and physical examination and total duration of the patient's symptoms:  
Blood and urine tests including urinalysis, urine cultures, complete blood count (CBC), BMP & PSA, 
BPH volume and other analysis measured using the most recent trans rectal ultrasound performed. 
 BPH treatment pre-operative preparations  
(according to hospital routine of care) 
7.5.1 
Anesthesia 
The subject will be put under regional (spinal) anesthesia or general anesthesia, per standard hospital 
practice for BPH procedures.  
7.5.2 
Preoperative antibiotics  
The subject will be given intravenous preoperative antibiotics per standard hospital practice. 
 Procedure 
7.6.1 
Cystoscopy and Fiber introduction 
The subject will be placed in dorsal lithotomy position. A 21 F cystoscope will be inserted through 
the urethra and the entire lower tract will be inspected to assess the degree of obstruction and to 
rule out presence of urethral stricture, bladder neck contracture or unexpected bladder pathology 
(tumors, stones). 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
The Xpeeda laser fiber will be introduced through the cystoscope and vaporization of the prostate 
is initiated (settings: frequency-60Hz, energy 2J, power-120W).  
7.6.2 
Vaporization  
Initially, a bladder neck groove is performed at the 5 o’clock and 7 o’clock positions with direct light 
contact with the tissue. If a significant median lobe is present, this will be vaporized between the 2 
grooves. 
Following this, the lateral lobes of the prostate will be vaporized from 1 o’clock to 5 o’clock, and 
from 11 o’clock to 7 o’clock positions. Next, the roof tissues will be vaporized from the level of the 
bladder neck to the level of the veru montanum if necessary. Lastly, apical tissues will be vaporized 
with care to avoid ablation of the veru montanum and external sphincter. Coagulation will be utilized 
as necessary (settings: frequency-20Hz, power-20W) 
At the end of the procedure, the entire lower tract will be inspected to assure an open channel and rule 
out any significant bleeding. A 22F catheter will be inserted – traction and continuous bladder irrigation 
can be utilized as necessary 
 Follow - up Regimen 
Each subject will be evaluated by the physician post the procedure as per standard of care to assess 
subject wellness. Subjects will be released from the hospital per the hospital standard practice. Each 
subject will return one month and 3 months following the procedure for a follow-up visits to assess 
prostate condition and subject well-being. Evaluations during each of these visits will be performed as 
described in Table 1. Additional unscheduled visits or examinations performed that are not part of the 
standard of care will be recorded in a dedicated Case Report Form (CRF). 
8 Study Analysis Plan 
 Study Analysis 
The results of the study: subject demographics, baseline assessments, treatment parameters, 
treatment evaluations and follow-up assessments will be summarized and descriptive analysis will be 
performed. Adverse events reported will be listed, documenting course, outcome, severity, and possible 
relationship to the treatment. The modified Clavien classification will be used to evaluate severity of 
Adverse Events [2]. 
 
 Interim report 
Interim analysis of the immediate post-operative data will be performed after at least 10 subjects 
underwent surgery in order to assess the immediate study results. If applicable, most of the study 
endpoint analysis will be performed for the initial 10 patients including ablation duration, safety 
parameters and secondary end-points (if applicable according to follow-up scheduled). Treatment 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
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safety and adverse events report, durations and all endpoints will be analyzed following the completion 
of all study subjects follow-up period and summarized in the final report. 
9 Adverse Events (AE) 
 Adverse Events Definitions 
9.1.1 
Adverse Event 
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 
9.1.2 
Adverse Device Effect 
Adverse event related to the use of an investigational medical device. Adverse Device Effect can be an 
anticipated serious adverse Device Effect which by its nature, incidence, severity or outcome has been 
identified in the risk analysis report or unanticipated if it has not been identified in the risk analysis 
report. 
9.1.3 
Serious Adverse Events 
NOTE: The term serious is not synonymous with severity, which may be used to describe the intensity 
of an event experienced by the subject. An AE that does not meet any of the below criteria will be 
classified as non-serious. 
A serious adverse event is any event that: 
4. led to death, 
5. led to serious deterioration in the health of the subject, that either resulted in: 
5.1. a life-threatening illness or injury, or 
5.2. a permanent impairment of a body structure or a body function, or 
5.3. in-patient or prolonged hospitalization, or 
5.4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
6. led to foetal distress, foetal death or a congenital abnormality or birth defect 
Any adverse events or complications reported by the patient or observed by the physician that occur 
during or after treatment with the device will be recorded in the medical record or source document and 
on the dedicated Case Report Form.  The investigator will determine if the AEs are device related or 
procedure related.  This assessment shall include the onset date, resolution date, severity, 
seriousness, frequency, additional treatment required and outcome.   
Each adverse event should be assessed according to the following criteria: 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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9.1.4 
Classification 
9.1.4.1 Severity (based on Clavien classification) 
Each adverse event should be assessed for its severity, or the intensity of an event experienced by 
the subject. 
 
Mild: Awareness of a sign or symptom that does not interfere with the subject’s activity or is 
transient resolved without treatment and has no sequelae. 
 
Moderate: May interfere with the subject’s usual activity and require additional intervention 
and/or treatment, and may have additional sequelae. 
 
Severe: Significant discomfort to the subject and/or interferes with the subject’s activity. 
Additional intervention and or treatment are necessary. Additional sequelae occur. Severe is 
used to describe the intensity of an event experienced by the subject.  
9.1.4.2 Relationship of AE to the Device 
Each adverse event should be assessed for its relationship to the device or procedure as identified as 
follows: 
 
Device: This category should be restricted to adverse events directly attributable to the 
vaporization procedure 
 
Procedure: This category should be restricted to adverse events inherent to the procedure 
irrespective of the fiber performance. 
Use the following categories for assigning the certainty of the relationship: 
 
Definitely Related: An AE is definitely related if it is obvious, certain or there is little doubt 
regarding the relationship 
 
Possibly Related: An AE is possibly related if it is capable of being related but relatively 
unlikely. 
 
Not Related: An AE is not related if it is determined that there is no plausible association. 
 
Unknown: Use this term if there is insufficient information to determine if the AE is related to 
the device or procedure. 
9.1.4.3 Pre-existing Conditions 
A pre-existing condition should not be reported as an adverse event unless there has been a 
substantial increase in severity or frequency of problems, which has not been attributed to natural 
history. 
9.1.4.4 Diagnosis 
There should be an attempt to report a “diagnosis” rather than the individual signs, symptoms and 
abnormal laboratory values associated with the diagnosis. However, a diagnosis should be reported 
only if, in the Investigator’s judgment, it is relatively certain (i.e., definite or possible). Otherwise 
individual signs, symptoms and abnormal laboratory values should be reported as the adverse events. 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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 Reporting 
9.2.1 
Adverse Events (AE) and Severe Adverse Events (SAE) Reporting 
All serious adverse events, whether or not deemed expected or device-related, must be reported to the 
clinical monitor immediately or within 24 hours of knowledge by telephone (see below). A written report 
must follow within five (5) working days and is to include a full description of the event and sequence.  If 
the Lumenis monitor cannot be reached, the site personnel will directly contact the Lumenis 
Communication Center (USA) at +1-877-586-3647. 
If an anticipated adverse event occurs at any time during or after the use of the study device, the 
Investigator must report it to Lumenis. If the anticipated adverse event, in the opinion of Lumenis or the 
Investigator, is likely to affect the safety of the subjects or the conduct of the study, the IRB/ethic 
committee will be notified of the effect as required by the authorized representative.  
The Investigator shall report to the EC and regulatory authorities serious adverse events and device 
deficiencies that could have led to a serious adverse device effect, if required by the national 
regulations or by the EC. 
 Risk/ Benefit Analysis 
9.3.1 
Anticipated Procedure Related Adverse Events 
Anticipated adverse events that are related to the BPH Vaporization procedure performed as part of 
this study and as established in the literature are noted below [Error! Reference source not found.]. 
hese complications are related to BPH Vaporization, whether or not ablation is performed, and 
regardless of the method that is used for either removal or the adenoma. 
 
Intraoperative complications: bleeding, prostate capsular perforation, infection and different risks 
due to the anesthesia 
 
Postoperative complications: Dysuria, hematuria, urge incontinence, urinary retention, urgency, 
infection 
9.3.2 
Anticipated Device Related Adverse Events 
The potential risks related to the system may include prostate capsule perforation and beelding. 
Nevertheless, this modified system is based on the previous marketed family of Ho:YAG lasers that is 
already largely used in the clinical arena, and for the same indications. The use of Ho:YAG for ablation 
of the prostate adenoma has been shown to be safe and effective with a very low rate of complications 
[Error! Reference source not found.Error! Reference source not found.]. 
Finally, the modified system underwent a thorough series of pre- clinical verification and validation 
testing to ascertain its maintained safety and performance as well as the safe and effective use of the 
Xpeeda fibers. 
9.3.3 
Anticipated Benefits 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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The Holmium laser has been shown to be able to vaporize soft tissues and in particularly prostate 
adenoma diagnosed as BPH. Duo to the high-energy power of the Lumenis pulse 120H and the usage 
of side firing fiber this tissue can be ablated quite easily. The Xpeeda fiber was design to work in full 
contact with the tissue thus delivering maximum energy for efficient vaporization. Bleeding control is 
successfully utilized with the holmium laser and the specific settings of the Lumenis pulse 120H. Using 
fiber defocusing or wider pulse size (predefined settings designed for the double puddle of the device) 
will minimize intraoperative complications. Moreover, the vaporization efficacy of the pulse 120H may 
lead to reduced procedure time and postoperative complications, including readmission as compared to 
the other commonly used parameters and devices for BPH treatment. 
10 Administrative Procedures 
 Investigator Selection 
The investigator must be of good standing as an investigator and knowledgeable in relevant areas of 
clinical research to ensure adherence to the requirements of the protocol, including the protection of 
human subjects.  Other site personnel must have appropriate research experience and infrastructure to 
ensure adherence to the protocol and enrollment of sufficient numbers of evaluable subjects. The 
curriculum vitae (CV) of the Investigator will be maintained in the Sponsor files as documentation of 
previous medical training, and federal databases will be searched to ensure that the investigator and/or 
the site are not prohibited from engaging in federally sponsored clinical research.  The Principal 
Investigator will sign the signature page of this protocol, agreeing to comply with all applicable 
government regulations and the requirements of this study. 
 IRB / Ethical Committee Approval 
This clinical study will be conducted according to all applicable regulations under the Medical Device 
Directive and in accordance with the ICH Good Clinical Practice and local laws and regulations relevant 
to the use of medical devices. 
An Ethical Committee (EC or IRB) will approve the clinical study protocol prior to study initiation. 
Approval will be indicated in writing with reference to the final protocol number and date. 
Details regarding the IRB / EC 's constitution including the names of its members, their qualifications 
and what function they perform on the board (e.g., chairman, specialist, lay-member) will be made 
available to enable Lumenis and the Investigator to conform to regulations governing research on 
experimental devices. 
 Informed Consent 
Prior to the procedure, the Investigator or his delegate must explain to each subject (or the subject’s 
legally authorized representative) the nature of the study, its purpose, expected duration, and the 
benefits and risks of study participation.  After this explanation and before entering the study, the 
subject (or legally authorized representative) must voluntarily sign and date the IRB (EC) -approved 
Informed Consent form. 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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 Subject Withdrawal/Dropouts 
The subjects will be advised in the written Informed Consent form that they have the right to withdraw 
from the study at any time without prejudice, and may be withdrawn at the Investigator’s/Lumenis’ 
discretion at any time. In the event that a subject drops out of the study or is withdrawn from the study, 
the Exit/Termination CRF should be completed. On the withdrawal page, the Investigator should record 
the date of the withdrawal, the person who initiated withdrawal and the reason for withdrawal. 
Reasonable effort should be made to contact any subject lost to follow-up during the course of the 
study in order to complete assessments and retrieve any outstanding data and study supplies. The 
records of subjects who terminate prior to completing the study will be retained and the reason for 
termination will be documented. 
The following are possible reasons for subject dropout/withdrawal: 
 
Adverse event that would prevent subject compliance with the protocol; 
 
Subject withdrawal of consent; 
However, every effort should be made to see that subject is followed for the remainder of the study 
even if subject is unable or unwilling to comply with the protocol. 
 Case Report Forms/Data Collection  
The Investigator is responsible for completely and accurately recording study data in the appropriate 
sections of the CRFs provided by Lumenis.  The CRFs must be signed by the Investigator or by his/her 
authorized person as designated in a note to file. 
The monitor will ensure the quality of data recording at each investigational site by comparison to 
supporting source documents during periodic site visits.  Adherence to proper recording of information 
as well as assuring that corrections are being made will also be addressed during these periodic visits. 
Data will be recorded on the following CRFs. Where data is not located in the subject’s source file, the 
CRF will be the source for this data. 
 Required Documentation 
Prior to starting the clinical study, the following documents must be submitted or returned to Lumenis by 
the Investigator: 
 
Signed Clinical Trial Acknowledgement for the protocol  
 
Signed Clinical Evaluation Agreement 
 
Curriculum vitae of the Principal Investigator 
 
Signed Financial Disclosure Statement for each investigator 
 
Written approval from the Ethical Committee of both the protocol and informed consent form 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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 Subject’s Financial Compensation 
Subjects participating in this study will not be compensated for participating in this study.  
 Device Use/Accountability 
The evaluation site personnel will maintain records of the model and serial number of the device (if 
appropriate) used for each treatment during the conduct of the study. The device along with the 
associated delivery and accessories are to be maintained by the research sponsor with reasonable 
care being taken by the Investigators and facility to prevent damage to, or unauthorized use of the 
equipment.  
 Training Requirements 
PI and all study personnel are well familiar with the procedure and device operation including all related 
tools and equipment. No training or additional instructions are required prior to study initiation. 
 Modification of Protocol 
The protocol may be amended with the agreement of the sponsor and upon notification of and approval 
by the IRB / EC. 
Investigators should review the contents of this protocol.  Subsequent alterations should only be made 
in writing in conjunction with the sponsor.  
Medically significant amendments to the protocol (e.g., changes that increase the risk or the 
inconveniences for the patient, inclusion of new categories of patients, significant modifications to the 
study device, etc.) must be approved by the local IRB / EC prior to implementation and authorized 
representative, as applicable.  
 Data Retention/Archiving Data 
The Investigator must keep the following documents in a secure place for at least 2 years after the last 
clearance of a marketing application or at least 2 years have elapsed since the formal discontinuation 
of clinical development of the investigational product. 
 
A signed copy of the final protocol and amendments. 
 
Copies of the subjects’ evaluation forms, data clarification forms and any associated 
subject-related raw data or where applicable, authorized copies of raw data. 
 
The subjects’ signed Informed Consent forms. 
 Site Monitoring 
The study monitors are designated as agents of Lumenis and are assigned to oversee the conduct and 
progress of the study and to be the principal communication link between Lumenis and investigator.  
The study monitors will be involved in monitoring of sites and records, to ensure continued compliance 
with the protocol and adequacy of the investigator and the facility to carry out the study.   

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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The study will be monitored by representatives of Lumenis Medical, Ltd. by telephone, in writing and 
during on-site visits.  At a minimum, site visits will be scheduled prior to the initiation of the study, and at 
the end of the study.  The purpose of site visits will be to ensure compliance with the investigational 
plan, to ensure appropriate use of investigational devices, and to inspect and retrieve study data. 
 Termination of Study 
Lumenis reserves the right to discontinue the study at any time for administrative or other reasons.  
Written notice of study termination will be submitted to the investigator in advance of such termination.  
Termination of a specific site can occur because of (but is not limited to) inadequate data collection, low 
subject enrollment rate, achievement of the total enrollment, or non-compliance with the protocol or 
other clinical research requirements 
 Reporting Requirements 
The investigator must promptly report to Lumenis any withdrawal of IRB / EC approval at the site.  
Additional reporting requirements include: 
 
Notify Lumenis’ designee and the IRB / EC of any severe adverse device effect, whether 
anticipated or unanticipated, that occurs during the study as soon as possible, but in no event 
later than 10 working days after the investigator first learns of the effect. This report is to include 
a description of the effect, subsequent treatments, clinical outcomes, and outcome diagnoses.  
If the site personnel are not sure whether an event meets these criteria, they should call the 
clinical monitor. 
 
Notify Lumenis or Lumenis’s designee and the IRB / EC immediately (within 24 hours) if an 
emergency situation arises in which the subsequent treatment, in the best interests of the 
subject, resulted in a deviation from the protocol.  This should be followed with written 
confirmation that describes the emergency action and outcomes, to Lumenis and the IRB / EC 
within 5 working days. 
 
Report to the IRB / EC and Lumenis, within 5 working days, the use of the study device without 
signed informed consent from the subject. 
 
Report adverse events in accordance with 21 CFR 803. 
 
Submit regular progress reports to the IRB / EC and Lumenis or Lumenis’ designee, as 
requested by the investigators or IRB/ EC. 
 
Submitting a final report on the study to the IRB / EC and Lumenis or Lumenis’s designee within 
3 months after termination or completion of the study. 
11 References  
1. Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of 
clinical outcomes and complication rates during 10 years of followup. J Urol. 2011 Nov;186(5):1972-
6.  

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
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ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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2. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with 
evaluation in a cohort of a 6336 patients and results of a survey. Ann Surg 2004;240:205–13 
3. Kumar, S. Holmium Laser Ablation of Large Prostate Glands: An Endourologic Alternative to Open 
Prostatectomy. Journal of Endourology, Vol 21, No. 6, June 2007 
4. Barski D, Richter M, Winter C, Arsov C, De Geeter P, Rabenalt R, Albers P. Holmium Laser 
Ablation of the Prostate (HoLAP): Intermediate term results of 144 patients. World J Urol, 31: 1253-
1259, 11Jul2013 
5. Brewer S. My Surgical Approach for BPH: A Retrospective of Multiple Options and Current Results.  
6. Gravas S, Bachmann A, Reich O, Roehrborn C, Gilling P, De La Rosette J. Critical Review of 
Lasers in Benign Prostatic Hyperplasia (BPH). BJU International, 107, 1030-1043, 14Sep2010. 
7. Tooher R, Sutherland P, Costello A, Gilling P, Rees G, Maddern G. A Systematic Review of 
Holmium Laser Prostatectomy for Bening Prostatic Hyperplasia. The Journal of Urology, vol. 171, 
1773-1781, May 2004. 
8. Leo M. Enhanced Prostate Vaporization Using High Power Holmium and Improved Fiber. World 
Congress of Endourology, submitted 21Jun2015. 
 
 
 
 
12 Abbreviations and Terms 
 
 
 
 
CBC 
Cell blood count 
AE 
Adverse Event 
SAE 
Serious Adverse Event 
BUN 
Blood urea nitrogen 
CRF 
Case Report Form 
IRB 
Institutional Review Board 
EC 
Ethical Committee 
Ho:YAG 
Holmium 
CT 
Computer Tomography 
US 
Ultrasound Sonography 
Hz 
Hertz (frequency unit) 
J 
BMP 
PSA 
Joule (energy unit) 
Basic Metabolic Panel 
Prostate Specific Antigen 
W 
Watt (power unit) 
KUB x-ray 
Kidney, ureter, bladder x-ray 
 
 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
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13 Appendices 
Appendix I 
Study Flow Chart  
Assessment 
 
Performed During Visit 
Baseline  
(Pre-
operative) 
 
Perioperative Hospital  
discharge 
1 
month 
follow-
up 
3 
month 
follow-
up 
Subject assessment  
(ICF, medical history, 
demographics, 
inclusion/exclusion 
evaluation) 
X 
 
 
 
 
 
 
Trans Rectal Ultrasound 
X 
 
 
 
X 
Post Void Residual 
Ultrasound 
X 
 
 
X 
X 
Q-Max Uroflow 
X 
 
 
X 
X 
Urodynamic Evaluation 
X 
 
 
 
 
Blood analysis 
(CBC, BMP & PSA) & urine 
analysis 
X 
X (CBC) 
 
 
X 
Urine culture (if applicable) 
X 
 
 
 
X 
Erectile Dysfunction 
X 
 
 
 
X 
Subject Questionnaires 
(AUA, QoL) 
X 
 
 
X 
X 
Physician Subjective 
Procedure Questionnaire 
 
X 
 
 
 
Adverse Event Assessment 
 
X 
X 
X 
X 
 

        
                                             
  
 
 
Description: Surgical. Protocol LUM-SBU-VP-15-02, Ablation 
efficacy of contact side firing fiber in predefined settings for 
treating BPH 
DOC No.: 1005715 
 
Revision: B 
State: Released 
ECO No: GEN-0007426 
Effective Date: 02-Jun-2016 
 
1000046   Rev. B                                                                                                                   GEN-0001153         
Page 
 
 
 
Confidential 
Appendix II 
Clinical Trial Acknowledgement 
 
I have read and understand the foregoing protocol, and agree to conduct the clinical trial as outlined 
herein and in accordance with Good Clinical Practices (ICH-E6) as well as with local and universal 
regulations pertaining to clinical trials. 
 
 
 
Investigator’s Signature 
 
Date 
Name 
 
 
Clinic 
 
 
Street Address 
 
 
City, State & Zip Code 
 
 
Country 
 
 
Phone # 
 
 
Fax # 
 
 
E-mail Address