Safety and Clinical Validation Study of the Plan A Delivery Lumen Access Device (DLAD)
Phase: NA
Conditions: Healthy Male Adults Participants, Vasectomy
Sponsor: Next Life Sciences

 
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CIP100C Rev A                                                    
 
 
 
 
 
Peri-vasectomy safety and clinical validation study of the Plan ATM 
Delivery Lumen Access Device (DLAD)  
 
Protocol CIP100C 
 
 
Rev A 
April 8, 2025 
 
 
Sponsor 
NEXT Life Sciences, Inc. 
1241 Johnson Ave #343 
San Luis Obispo, CA 93401 
 
Clinical Research Site (Quebec, Canada) 
VasectoPro 
1101 Bd Wilfrid-Hamel, Suite 101 
Quebec City QC  
Canada 
G1H7B5  
 
Manufacturer 
NEXT Life Sciences, Inc. 
13240 Evening Creek Drive S., Suite 304 
San Diego, CA  92128 
United States of America 
Phone: +1 
6398
-
(209) 870
 
www.nextlifesciences.org 
 
 
C O N F I D E N T I A L:  This clinical investigational plan contains confidential information for 
use by the principal investigators and their designated representatives participating in this 
clinical investigation.  It should be held confidential and maintained in a secure location.  It 
should not be copied or made available for review by any unauthorized person or firm without 
written permission from NEXT Life Sciences, Inc. 
 

 
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CIP100C Rev A                                                    
 
SIGNATURE PAGE 
By signing below, I confirm that I have read and will abide by this protocol, the signed investigator agreement and 
all applicable regulations. 
 
 
 
Principal Investigator’s Name (print) 
 
 
Principal Investigator’s Signature 
 
Date 
(DD/MMM/YYYY) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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CIP100C Rev A                                                    
 
TABLE OF CONTENTS 
 
 
REVISION HISTORY ........................................................................................... 5 
INVESTIGATIONAL PLAN SUMMARY .............................................................. 6 
TRIAL CONTACTS .............................................................................................. 7 
1. 
INTRODUCTION ........................................................................................... 8 
2. 
INVESTIGATOR BROCHURE...................................................................... 9 
3. 
INVESTIGATIONAL DEVICE DESCRIPTION .............................................. 9 
3.1. 
DEVICE DESCRIPTION ......................................................................................9 
3.2. 
DEVICE MODEL NUMBER..............................................................................11 
3.3. 
INDICATIONS FOR USE ..................................................................................11 
3.4. 
TRAINING AND EXPERIENCE .......................................................................11 
4. 
STUDY PROTOCOL ................................................................................... 11 
4.1. 
OBJECTIVES AND HYPOTHESIS ...................................................................11 
4.1.1 OBJECTIVES ......................................................................................................11 
4.1.2 HYPOTHESIS .....................................................................................................12 
4.2. 
STUDY DESIGN.................................................................................................12 
4.3. 
MEASURES TAKEN TO MINIMIZE OR AVOID BIAS .................................12 
4.4. 
STUDY SAMPLE SIZE ......................................................................................12 
4.5. 
STUDY DURATION ..........................................................................................12 
4.6. 
PRIMARY SAFETY OUTCOME MEASURE ..................................................12 
4.7. 
PRIMARY PRODUCT PERFORMANCE MEASURES ...................................13 
4.8. 
ADDITIONAL DATA ANALYSES ...................................................................13 
4.9. 
STUDY POPULATION ......................................................................................13 
4.10. INCLUSION/EXCLUSION CRITERIA .............................................................13 
4.10.1  INCLUSION CRITERIA....................................................................................13 
4.10.2  EXCLUSION CRITERIA ..................................................................................13 
4.11. SUBJECT PRE-SCREENING.............................................................................14 
4.11.1 RECRUITMENT .................................................................................................14 
4.11.2   INITIAL SCREEN.............................................................................................14 
4.12. SUBJECT SCREENING .....................................................................................15 
4.13. INFORMED CONSENT .....................................................................................15 
4.14. ENROLLMENT ..................................................................................................15 
4.15. TREATMENT .....................................................................................................15 
4.16. SUBJECT WITHDRAWAL ................................................................................15 
4.17. STUDY/SITE SUSPENSION OR EARLY TERMINATION ............................15 
5. 
STUDY PROCEDURES .............................................................................. 16 
5.1. 
STUDY SCHEDULE OF ASSESSMENTS .......................................................16 
5.2. 
BASELINE EVALUATIONS .............................................................................17 
5.2.1 EVALUATIONS .................................................................................................17 
5.3. 
DELIVERY LUMEN ACCESS DEVICE (DLAD) USE ...................................17 
5.3.1 PREPARATION ..................................................................................................17 
5.3.2 ACTIVE INFECTION EVALUATION ..............................................................18 
5.3.3 SUBJECT ANESTHESIA AND SETTING OF CARE ......................................18 
5.3.4 DLAD PROCEDURE ..........................................................................................18 

 
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CIP100C Rev A                                                    
5.3.5 VASECTOMY .....................................................................................................18 
5.3.6 POST-PROCEDURE ...........................................................................................18 
5.3.7 PHYSICIAN USABILITY AND ERGONOMICS .............................................18 
5.4 
INVESTIGATIONAL PRODUCT DISPOSITION ............................................18 
5.5 
FOLLOW-UP ASSESSMENTS ..........................................................................18 
5.5.1 14-DAY FOLLOW-UP (+/-3 days) .....................................................................18 
5.5.2 UNSCHEDULED VISIT ......................................................................................19 
5.6 
TERMINATION ..................................................................................................19 
5.7 
PROTOCOL DEVIATIONS ...............................................................................19 
6 
ADVERSE EVENTS ................................................................................... 19 
6.1 
DEFINITIONS .....................................................................................................19 
6.2 
ADVERSE EVENT REPORTING......................................................................23 
6.3 
MEDICAL MONITOR REVIEW OF ADVERSE EVENTS .............................23 
6.4 
DEVICE DEFICIENCIES ...................................................................................24 
6.5 
DEVICE MALFUNCTION .................................................................................24 
6.6 
USE ERROR ........................................................................................................24 
7 
RISK AND BENEFITS ................................................................................ 24 
7.1 
POTENTIAL RISKS ...........................................................................................24 
7.2 
MINIMIZATION OF ANTICIPATED RISKS ...................................................25 
7.3 
POTENTIAL RISKS TO SUBJECT CONFIDENTIALITY ..............................26 
7.4 
POTENTIAL BENEFITS ....................................................................................26 
8 
STATISTICAL METHODOLOGY AND ANALYSIS .................................... 26 
9 
DATA MONITORING AND QUALITY CONTROL ...................................... 27 
9.1 
CASE REPORT FORMS (CRF) .........................................................................27 
9.2 
DATA COLLECTION ........................................................................................27 
9.3 
MONITORING OF CLINICAL SITES AND INVESTIGATORS ....................28 
10 STUDY MANAGEMENT AND RESPONSIBILITIES .................................. 28 
10.1 SPONSOR RESPONSIBILITIES .......................................................................28 
10.2 INVESTIGATOR RESPONSIBILITIES ............................................................30 
10.3 ETHICAL CONSIDERATIONS .........................................................................31 
10.4 INFORMED CONSENT .....................................................................................32 
10.5 SUBJECT CONFIDENTIALITY ........................................................................32 
10.6 SELECTION AND TRAINING OF CLINICAL SITES AND  
 
INVESTIGATORS ..............................................................................................33 
10.7 SITE QUALIFICATION .....................................................................................33 
10.8 PRE-STUDY TRAINING ...................................................................................33 
10.9 RECORD RETENTION ......................................................................................34 
10.10 MAINTAINING RECORDS ...............................................................................34 
10.11 DEVICE ACCOUNTABILITY...........................................................................34 
10.12 TRIAL CLOSEOUT ............................................................................................34 
10.13 AUDITS AND INSPECTIONS ...........................................................................35 
10.14 PUBLICATION POLICY AND FINAL REPORT .............................................35 
 
 
 

 
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CIP100C Rev A                                                    
 
 
REVISION HISTORY 
 
Version 
Effective Date 
Justification for Revision 
A 
4/8/2025 
Initial version. 
 
 
 
 

 
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CIP100C Rev A                                                    
INVESTIGATIONAL PLAN SUMMARY 
Title 
Peri-vasectomy safety and clinical validation study of the Plan ATM 
Delivery Lumen Access Device (DLAD) 
Protocol No. 
CIP100C 
Version 
Revision A, April 8, 2025 
Sponsor 
NEXT Life Sciences, Inc. 
Device Name 
Plan A™ Delivery Lumen Access Device (DLAD) 
Study Design 
Prospective, multi-center, single-arm, open label, clinical validation 
trial 
Study 
Objectives 
1. Evaluate the safety and performance of DLAD for: 
a. Entering the lumen of the vas deferens 
b. Passing a guidewire 5cm into the lumen of the vas 
deferens 
c. Insertion of the 2Fr sheath over the guidewire 1cm to 
1.5cm into the vas deferens lumen 
d. Delivery of saline into the vas deferens 
e. Removal of the DLAD system 
2. Obtain physician user feedback  
Primary Safety 
Outcome 
Measure 
Collection of all adverse events, analyzed by seriousness, severity, 
device relatedness, procedure relatedness and whether anticipated 
Primary 
Product 
Performance 
Measures 
1. Physician usability  
2. Intraluminal access to the vas deferens evaluating each of 
following: 
- 
Visual confirmation that the guidewire or the sheath are not 
outside of the vas deferens 
- 
Tactile sensation that the guidewire and sheath were inserted 
with ease into the vas deferens lumen 
- 
Easy flow of saline into the vas deferens lumen 
- 
Visual confirmation that saline has not accumulated into the 
tissues outside of the vas deferens 
Additional 
Analyses 
Physician ergonomics 
Sample Size 
Up to 30 male subjects will be consented, screened and enrolled 
with a goal to have a minimum of 20 subjects with evaluable data. 
Study sites in the United States will enroll a maximum of 10 subjects 
who undergo the procedure within the overall sample size of 30. 
Study 
Duration 
An estimated total of up to 3 months for screening, enrollment and 
follow-up 
Follow-up 
2-week follow-up for adverse event assessment 
Investigational 
Site 
Information 
This study may be conducted at up to 5 centers.  Study sites may be 
in the United States and/or outside the United States. 

 
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CIP100C Rev A                                                    
 
TRIAL CONTACTS 
Please refer to the current trial contact list provided separately.  
 
 
 
 

 
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CIP100C Rev A                                                    
1. INTRODUCTION 
NEXT Life Sciences is developing the Plan ATM Male Contraceptive System to address the global 
problem of unintended pregnancies that total 121 million each year according to the State of 
World Population report (UNFPA, 2022).  Globally, an estimated 257 million women who want to 
avoid pregnancy are not using safe, modern methods of contraception. 
 
The current options for contraception and family planning focus mostly on female fertility, 
burdening women with a majority of the responsibility for reproductive planning.  Male birth 
control options have traditionally been limited to vasectomy, condoms, and withdrawal.  
Vasectomy is effective but reversal is expensive and unpredictable.  Condoms reduce disease 
transmission, but their pregnancy protection failure rate in typical use is 13%.  The withdrawal 
method typically has an even higher failure rate. 
 
The development of a non-hormonal, long-lasting, and reversible male birth control option would 
offer a greater choice of birth control for both individuals and couples when planning their future.  
The mission of NEXT Life Sciences is to design and develop that new option through Plan A™.   
 
The Plan A™ Male Contraceptive System utilizes a proprietary hydrogel, called Vasalgel®.  The 
Plan A™ Occlusion System includes Vasalgel®, which is intended to occlude the vas deferens, and 
the Delivery Lumen Access Device (DLAD), which is intended to deliver the Vasalgel® into the vas 
deferens.  Vasalgel® can be characterized as a soft solid implant and is intended to act as a flexible 
barrier to sperm.  The Plan A™ Reversal System is designed to remove Vasalgel® from the vas 
deferens with the administration of sodium bicarbonate into the vas deferens using the Reversal 
Lumen Access Device (RLAD) to restore the flow of sperm. 
 
The company is embarking on a series of clinical trials to evaluate the Plan A™ Male Contraceptive 
System.  The clinical development plan includes six studies across two phases.  
 
First Phase - Feasibility studies:  
 
a. Peri-vasectomy safety and clinical validation of the Delivery Lumen Access Device 
(DLAD) to access the vas deferens  
 
b. Local reaction safety of Vasalgel®  
 
c. Safety and feasibility of the Plan A™ Occlusion System and procedure to occlude the 
vas deferens  
 
d. Safety and feasibility of the Plan A™ Reversal System and procedure to reverse the 
occlusion achieved with the Plan A™ Occlusion System  
 

 
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CIP100C Rev A                                                    
Second Phase - Pivotal trials: 
 
a. Safety and effectiveness evaluation of Plan A™ Male Contraceptive System  
 
b. Safety and effectiveness evaluation of reversing Plan A™ Male Contraception  
 
The study described herein is the first trial within the first phase of feasibility studies.  This trial 
is intended to evaluate the safety and clinical validation of the Delivery Lumen Access Device 
(DLAD) to achieve intraluminal access to the vas deferens immediately prior to a scheduled 
vasectomy.  Vasalgel® will not be evaluated in this study.   
 
2. INVESTIGATOR BROCHURE 
An Investigator Brochure will provide a detailed summary of the prior pre-clinical testing of the 
Plan A™ Delivery Lumen Access Device.  
3. INVESTIGATIONAL DEVICE DESCRIPTION 
3.1. DEVICE DESCRIPTION 
The complete Plan A™ Male Contraceptive System is comprised of the following: 
• Plan A™ Occlusion System: 
o Vasalgel® 
o Delivery Lumen Access Device (DLAD) 
 
• Plan A™ Reversal System: 
o Reversal Lumen Access Device (RLAD) 
o Irrigation tubing to connect to 8.4% USP, sterile for injection sodium 
bicarbonate solution and aspiration tubing to connect to the aspiration 
device 
 
The Plan A™ occlusion procedure will require the following commercially available products 
to be provided by the user:  ring clamps, dissecting forceps, gauze, local anesthetic, 
hypodermic needle and syringe, and closing tape. 
  
The Plan A™ reversal procedure will require the following commercially available products to 
be provided by the user:  ring clamps, dissecting forceps, gauze, local anesthetic, hypodermic 
needle and syringe, and closing tape, 8.4% USP, sterile for injection sodium bicarbonate 
solution and aspiration device. 
 
The Delivery Lumen Access Device (DLAD) being evaluated in this study is discussed in more 
detail below. 
 
 

 
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CIP100C Rev A                                                    
Delivery Lumen Access Device (DLAD) 
The Delivery Lumen Access Device (DLAD) is intended to deliver Vasalgel® into the vas 
deferens to block the flow of sperm.  In this study, the DLAD will be used to deliver saline into 
the vas deferens.  The single-use, sterile DLAD is comprised of a 2Fr Sheath Assembly, a 0.014” 
Guidewire Assembly, and a Handle Assembly.  These components are shown below in Figures 
1 and 2.  Two DLAD devices, one for each vas deferens, are required for the procedure. 
 
Figure 1.  DLAD Sheath Assembly with Preloaded Guidewire Assembly 
 
 
Figure 2.  DLAD Sheath Assembly Cartridge and Handle Assembly 
 
 
Vasalgel® will not be delivered or evaluated in this study. 
 
 
 
 
 

 
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CIP100C Rev A                                                    
3.2. DEVICE MODEL NUMBER 
The current device model number is provided in Table 1. 
 
Table 1.  Device Model Number 
Note:  Model numbers may change during the course of the study according to the company’s 
Quality System process. 
Description 
Code / Model Number 
Plan A™ Delivery Lumen Access Device 
DLAD 1000 
Accessory Items (provided by the institution) 
Use of DLAD for this study will require the following commercially available products 
to be provided by the user:  ring clamps, dissecting forceps, gauze, local anesthetic, 
hypodermic needle and syringe, closing tape, and sterile saline. 
 
3.3. INDICATIONS FOR USE 
DLAD is a component of the Plan ATM Male Contraceptive System that is being developed to 
support the following future commercial Indications for Use: 
 
The Plan ATM Male Contraceptive System is intended for men age 18 or over who desire a 
long-acting, reversible contraceptive method by occlusion of the vas deferens. 
 
The DLAD is intended to deliver Vasalgel® into the vas deferens to block the flow of sperm.  
In this study, the device will be used to deliver 5.1 ml of sterile saline into the vas deferens 
immediately prior to a scheduled vasectomy.  Vasalgel® will not be delivered or evaluated in 
the clinical study. 
3.4. TRAINING AND EXPERIENCE 
Investigators must have sufficient experience in performing no scalpel vasectomy procedures 
within males seeking permanent sterilization and experience in performing vas deferens 
luminal access procedures such as a vasogram or mucosal cautery during vasectomy.   
 
Prior to using the investigational DLAD, Investigators must: 
 
• 
Undergo device use training conducted by NEXT personnel or designee; 
 
• 
Ensure adjunct personnel are also familiar with the training materials prior to 
use of the DLAD. 
4. STUDY PROTOCOL 
4.1. OBJECTIVES AND HYPOTHESIS 
4.1.1 OBJECTIVES 
o Evaluate the performance of DLAD for: 

 
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CIP100C Rev A                                                    
- 
Entering the lumen of the vas deferens  
- 
Passing a guidewire 5cm into the lumen of the vas deferens 
- 
Insertion of the 2Fr sheath over the guidewire 1cm to 1.5cm into the vas 
deferens lumen 
- 
Delivery of 5.1 ml of sterile saline into the vas deferens 
- 
Removal of the DLAD system 
o Obtain physician user feedback 
4.1.2 
HYPOTHESIS 
There is no formal hypothesis testing as this is a feasibility study. 
4.2. STUDY DESIGN 
This study is a prospective, multicenter, single-arm, open label, clinical validation trial.  A 
graphic of the study design is presented below in Figure 3.   
 
Figure 3.  Study Design  
 
 
4.3. MEASURES TAKEN TO MINIMIZE OR AVOID BIAS 
Bias will be minimized in this study by utilizing objective eligibility criteria.  
4.4. STUDY SAMPLE SIZE 
Up to 30 male subjects may be consented, screened and enrolled with a goal to have a 
minimum of 20 evaluable subjects.  A study site in Australia will enroll a maximum of 10 
subjects who undergo the procedure within the overall sample size of 30. 
4.5. STUDY DURATION 
Study duration is an estimated total of up to three (3) months for screening, enrollment and 
follow-up.  
4.6. PRIMARY SAFETY OUTCOME MEASURE 
The primary safety outcome measure will be collection of all adverse events analyzed by 
seriousness, severity, device relatedness, procedure relatedness and whether anticipated.  

 
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CIP100C Rev A                                                    
4.7. PRIMARY PRODUCT PERFORMANCE MEASURES 
The primary product performance measures are: 
- 
Physician usability  
- 
Intraluminal access to the vas deferens evaluating each of the following: 
o Visual confirmation that the guidewire or the sheath are not outside of the vas 
deferens 
o Tactile sensation that the guidewire and sheath were inserted with ease into the 
vas deferens lumen 
o Easy flow of saline into the vas deferens lumen 
o Visual confirmation that saline has not accumulated into the tissues outside of 
the vas deferens 
4.8. ADDITIONAL DATA ANALYSES 
Planned additional analyses include the following: 
- 
Physician ergonomics 
4.9. STUDY POPULATION 
The study population will include male subjects who have already planned to undergo a 
vasectomy.  Subjects must provide written informed consent and meet the study entry 
criteria noted below. 
4.10. INCLUSION/EXCLUSION CRITERIA 
4.10.1 INCLUSION CRITERIA 
A subject must meet all the following criteria to participate in this study:  
1. Male subject who has already planned to undergo a vasectomy 
2. Male subject who has voluntarily signed and dated the Institutional Review Board 
(IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study 
prior to initiation of any screening or study specific procedures 
3. 18 to 65 years of age at the time of consent  
4. Good health for undergoing a vasectomy as confirmed by medical history and 
physical examination  
5. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a 
form of long-term contraception 
4.10.2 EXCLUSION CRITERIA 
A subject will be excluded from participating in the study if any of the following 
conditions apply:  
1. On exam, has any of the following:  one or both vasa not present, abnormal 
scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or 
intrascrotal mass that would make the subject not suitable for the study 
2. Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy 
(vasectomy reversal)  

 
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CIP100C Rev A                                                    
3. Has local genital infections such as balanitis, scrotal skin infection, epididymitis, 
or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution 
of an acute infection 
4. History of prostatitis or benign prostatic hypertrophy requiring treatment 
5. Has known current coagulopathy or other bleeding disorders  
6. Known allergy to DLAD materials, including nickel, stainless steel and silicone 
7. Has cystic fibrosis 
8. Has history of inguinal hernia repair 
9. Subject belongs to a vulnerable population.  Vulnerable subject populations are 
defined as individuals who are incarcerated, handicapped, have cognitive challenges, 
mental disability, persons in nursing homes, children, impoverished persons, 
homeless persons, economically or educationally disadvantaged persons, nomads, 
refugees and those permanently incapable of giving informed consent.  Vulnerable 
populations also may include members of a group with a hierarchical structure such 
as university students, subordinate hospital and laboratory personnel, employees of 
the sponsor, members of the armed forces and persons kept in detention. 
10. Currently participating in another study involving an investigational device or drug 
within the last 30 days prior to the first screening 
11. Any site staff member with delegated study responsibilities or a family member of 
a site staff member with delegated study responsibilities 
12. In the opinion of the Investigator, there are issues or concerns that may compromise 
the safety of the subject or confound the reliability of compliance and information 
acquired in this study 
13. Has any condition that, in the opinion of the Investigator, would interfere with evaluation 
of DLAD product performance or interpretation of patient safety or study results 
4.11. SUBJECT PRE-SCREENING 
4.11.1 RECRUITMENT 
Various forms of advertising may be deployed to recruit potential candidates for the 
study.  Men responding to the advertising may be directed to a study website, to an 
investigational site, be sent an informational email, or accept to be contacted by a 
research nurse to learn more about the study and continue with an initial screening 
process.  Men may also be informed about the study by their medical doctor at the time 
of a pre-vasectomy consultation. 
4.11.2  INITIAL SCREEN 
Potential study candidates will answer select inclusion/exclusion questions.  The study 
website or investigational site will inform the candidate if he is not eligible to continue 
with the screening process.   

 
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CIP100C Rev A                                                    
Recruitment and initial screening will be managed directly by site coordinators at 
centers where there is no advertising or a study website. 
4.12. SUBJECT SCREENING 
The Investigator or designee will perform an initial evaluation of the patient by reviewing the 
inclusion and exclusion criteria to determine study eligibility.  Study-specific evaluations may 
only be performed following informed consent.  A sample informed consent form is provided 
under a separate cover. 
4.13. INFORMED CONSENT 
Prior to the initiation of any study-specific procedures, the Investigator or his/her authorized 
designee will conduct the informed consent process with each subject as outlined in section 
10.4.  
4.14. ENROLLMENT  
A subject is considered enrolled after providing written informed consent and passing all 
required screening tests.  
4.15. TREATMENT  
A subject will be considered treated if the DLAD is inserted into at least one vas deferens, 
regardless of whether the procedure can be completed. 
4.16. SUBJECT WITHDRAWAL 
A study subject may be discontinued for the following reasons: 
• Subject Withdrawal:  Withdrawal in a clinical trial is voluntary and the subject may 
choose to discontinue at any time and for any reason without penalty or loss of 
benefits. 
• Investigator Termination:  The Investigator may terminate the subject without 
regard to his consent if the Investigator believes it is medically necessary.  In the 
event of termination by the Investigator, reason for termination will be 
documented. 
• Sponsor Termination:  The Sponsor may terminate the site or study, and therefore 
subject participation based on section 4.17 of this clinical investigational plan. 
4.17. STUDY/SITE SUSPENSION OR EARLY TERMINATION 
The study can be discontinued at the discretion of the study Sponsor for reasons including, 
but not limited to, the following: 
• Occurrence of adverse events unknown to date in respect to their nature, severity, 
or duration, or the unexpected incidence of known adverse events; 
• Insufficient recruitment of subjects; 
• Unanticipated adverse device effect (UADE) presenting an unreasonable risk to 
subjects; 

 
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CIP100C Rev A                                                    
• Persistent non-compliance with the protocol; 
• Persistent non-compliance with IRB/EC or regulatory requirements; or  
• Business reasons. 
If the study is discontinued or suspended prematurely, the Sponsor will promptly inform the 
clinical Investigator/investigational center of the termination or suspension and the reason(s) 
for the termination or suspension.  The IRB/EC will also be informed promptly and provided 
with the reason(s) for the termination or suspension by the Sponsor or by the clinical 
Investigator/investigation center.   
5. STUDY PROCEDURES 
5.1. STUDY SCHEDULE OF ASSESSMENTS 
The study schedule of assessments is provided in Table 2. 
 
 

 
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CIP100C Rev A                                                    
 
Table 2.  Study Schedule of Assessments 
 
Assessments 
Screening 
Within 30 days prior to 
procedure                 
DLAD Use  Procedure  
 
14-Day 
+/-3 days 
           
Unscheduled Visit  
Visit Type 
Clinic or 
phone 
Clinic 
Phone* 
Clinic 
Study Informed Consent 
X** 
X 
 
 
Demographics 
X 
 
 
 
Medical History 
X 
 
 
 
Physical Exam  
X*** 
 
 
 
Delivery Lumen Access Device (DLAD) Use**** 
 
X 
 
 
Physician Usability and Ergonomics Questionnaire 
 
X 
 
 
Adverse Event Evaluation 
 
X 
X 
X 
Concomitant Medication Review 
X 
X 
X 
X 
Vasectomy 
 
X 
 
 
* 14- day visit may be conducted in clinic if deemed necessary by the Investigator. 
** If screening is done by phone, the patient will be sent the consent form by e-mail and he will sign it on the 
day of the intervention. 
*** If screening is done by phone, the physical exam will be done on the day of the intervention. 
**** A total of 5.1ml of saline will be delivered into the vas deferens (100ul followed by 5ml).  
 
5.2. BASELINE EVALUATIONS 
5.2.1 
EVALUATIONS 
The following baseline evaluations must be completed within 30 days prior to DLAD use 
to verify eligibility per the inclusion and exclusion criteria. 
• Medical history 
• Physical exam  
• Concomitant Medication  
• Demographics 
 
5.3. DELIVERY LUMEN ACCESS DEVICE (DLAD) USE 
Within 30 days after all screening is completed, subjects will undergo DLAD use 
immediately prior to their planned vasectomy.  
5.3.1 
PREPARATION 
Subjects will be prepared for DLAD use per standard of care guidelines for conducting a 
vasectomy.   

 
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CIP100C Rev A                                                    
5.3.2 
ACTIVE INFECTION EVALUATION 
At the time of DLAD use, subjects exhibiting signs of active, local infection will be 
excluded from the study or delayed from the procedure.  Readmittance to the study will 
only occur when all signs of infection are clear in the judgment of the Investigator.  
5.3.3 
SUBJECT ANESTHESIA AND SETTING OF CARE 
The method and amount of anesthesia will be left to the discretion of the Investigator. 
The procedure may be performed in an office setting, ambulatory surgery center or in 
an operating room.  All procedure settings must be fully equipped to respond in case of 
an emergency. 
5.3.4 
DLAD PROCEDURE  
Please refer to the DLAD Directions For Use (DFU) for details on how to conduct the 
DLAD procedure.  
5.3.5 
VASECTOMY 
Directly following DLAD use, vasectomy will be performed according to standard of care. 
5.3.6 
POST-PROCEDURE  
Subjects will undergo post-procedure monitoring and recovery per standard of care for 
a vasectomy procedure.      
 
An assessment will be made for any procedure-related or device-related adverse events 
prior to discharge.   
5.3.7 
PHYSICIAN USABILITY AND ERGONOMICS 
The Investigator who used the DLAD will complete a usability and ergonomics 
questionnaire to provide feedback about device use. 
5.4 INVESTIGATIONAL PRODUCT DISPOSITION 
Disposition of all investigational product must be documented using the Device 
Accountability logs provided.  See section 10.11 for additional guidance regarding device 
accountability.  
5.5 FOLLOW-UP ASSESSMENTS 
5.5.1 
14-DAY FOLLOW-UP (+/-3 days) 
Subjects will be contacted by phone 14 days (+/- 3 days) following DLAD use to evaluate 
the following: 
• Adverse events 
 
• Change in medications 
 
The visit may be conducted in clinic if deemed necessary by the Investigator. 

 
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5.5.2 UNSCHEDULED VISIT 
At the Investigator’s discretion, a subject may be asked to return to the clinic for an 
unscheduled visit to assess an adverse event.  This information will be recorded on the 
adverse event Case Report Form.  Any associated changes to concomitant medications 
will also be recorded. 
5.6 TERMINATION 
The Subject Disposition case report form will be completed following the 14-day follow-up 
visit, or whenever study participation has been terminated.  Subjects will be instructed to 
return to their managing physician for routine care.  
If a subject does not complete the required follow-up, but has not officially withdrawn 
consent, then all reasonable efforts should be made by the site personnel to locate and 
communicate with the subject.  A minimum of three (3) attempts to contact the participant, 
preferably using different modes of communication (phone, email, letter) must be recorded 
before documenting the subject as lost to follow-up.  
5.7 PROTOCOL DEVIATIONS 
Except in the event of a medical emergency or where it is necessary to protect the safety, 
rights or welfare of the study subject, any changes to the protocol will require written 
approval of NEXT Life Sciences or designee and IRB/EC and government health authority, if 
applicable.  Deviations from the Clinical Investigational Plan to protect the health and safety 
of the subject will be reported to the IRB/EC and government health authority as required by 
applicable regulations. 
 
All deviations from the protocol should be recorded on the electronic case report forms 
(eCRFs).  A deviation may be identified by the Investigator, NEXT Life Sciences, or the 
monitoring staff.  Investigators will be asked to provide an explanation for the deviation.  
NEXT Life Sciences, or designee, will be responsible for analyzing deviations and will 
implement corrective actions as necessary. 
6 ADVERSE EVENTS 
6.1 DEFINITIONS 
Adverse Events (AE), per ISO 14155: 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical 
signs (including abnormal laboratory findings) in subjects, whether or not related to the 
medical device.  For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
 
Adverse Device Effect (ADE), per ISO 14155: 
Adverse event related to the use of an investigational medical device.  This definition includes 
any event resulting from insufficient or inadequate deployment, implantation, installation or 
operation or any malfunction of the investigational device. 
 

 
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Serious Adverse Events (including subject death) (SAE), per ISO 14155: 
The investigator must decide whether an event meets the definition of a ‘serious’ adverse 
event (SAE), which is an event that: 
a) led to a death, 
b) led to a serious deterioration in the health of the subject that either resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
NOTE 1:  This includes device deficiencies that might have led to a serious adverse event if:  a) suitable action 
had not been taken; or b) intervention had not been made; or c) if circumstances had been less fortunate.  These 
are handled under the SAE reporting system. 
 
NOTE 2:  A planned hospitalization for pre-existing condition, or a procedure required by the Clinical 
Investigational Plan, without a serious deterioration in health, is not considered to be a serious adverse event. 
 
Serious Adverse Device Effect (SADE), per ISO 14155: 
Any adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event or that might have led to any of these consequences if suitable action 
had not been taken or intervention had not been made or if circumstances had been less 
fortunate. 
 
Unanticipated Adverse Device Effect (UADE) per 21 CFR 812.150: 
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 a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.  
 
Severity Grading 
The Investigator will use the following Common Terminology Criteria for Adverse Events 
(CTCAE) definitions to grade the severity of each adverse event: 
 
Table 3.  Adverse Event Severity 
 
Severity Grade 
Description 
Grade 1  
Mild 
Asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
Grade 2  
Moderate 
Minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental ADL*. 

 
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Severity Grade 
Description 
Grade 3  
Severe 
Medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; 
disabling; limiting self-care ADL**. 
Grade 4  
Life Threatening 
Consequences 
Urgent intervention indicated. 
Grade 5 
Death 
Death related to AE 
Activities of Daily Living (ADL)  
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc.  
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not bedridden. 
 
 
 

 
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Adverse Event Relationship: 
 
The relationship of the adverse event to the Investigational device will be assessed according 
to the following definitions.  
 
Table 4.  Adverse Event Device Relationship 
 
Relationship 
Description 
Not Related 
• 
Not associated with device application 
• 
Due to an underlying or concurrent illness 
Unlikely 
• 
Little or no temporal relationship to the study device and/or 
• 
A more likely etiology exists 
Probable 
• 
Temporal sequence is relevant or 
• 
Event abates upon device application completion/removal or 
• 
Event cannot be reasonably explained by the patient’s condition 
 
Definitely Related 
• 
Has a reasonable temporal relationship to device application and 
• 
Could not readily have been produced by the patient’s clinical 
state or have been due to environmental or other interventions 
and 
• 
Follows a known pattern of response to intervention  
 
The relationship of the adverse event to the procedure will be assessed according to the 
following definitions.  
 
Table 5.  Adverse Event Procedure Relationship 
 
Relationship 
Description 
Not Related 
• 
Not associated with procedure 
• 
Due to an underlying or concurrent illness 
Unlikely 
• 
Little or no temporal relationship to procedure and/or 
• 
A more likely etiology exists 
Probable 
• 
Temporal sequence is relevant or 
• 
Event abates upon procedure completion or 
• 
Event cannot be reasonably explained by the patient’s condition 
Definitely Related 
• 
Has a reasonable temporal relationship to procedure and 
• 
Could not readily have been produced by the patient’s clinical 
state or have been due to environmental or other interventions 
and 
• 
Follows a known pattern of response to intervention  
 

 
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6.2 ADVERSE EVENT REPORTING 
Adverse event reporting will be performed in accordance with the applicable regulations and 
the requirements of the reviewing IRB/EC.  
 
All adverse events following the subject’s consent for study participation will be recorded in 
the subject’s medical records and eCRFs whether or not the AE is considered related to the 
investigational device.  All adverse events should be followed until they are adequately 
resolved or not expected to change.  Adverse events will be recorded on the eCRF by the 
Investigator or his/her designee.  However, it is the responsibility of the Investigator to ensure 
that all information is correct and appropriately documented. 
 
A list of adverse events that may result from the procedure can be found in the Risk and 
Benefit section of this protocol (section 7).   
 
The Investigator will submit to the Sponsor a report of any Serious Adverse Event (SAE), 
Serious Adverse Device Effect (SADE), Adverse Device Effect (ADE), or Unanticipated Adverse 
Device (UADE) occurring during an investigation according to the following schedule: 
 
Table 6. Adverse Event Reporting Schedule 
Type of Report 
Submission Schedule 
Adverse Device Effect (ADE) 
Report within 7 calendar days 
Patient Death 
Report within 2 calendar days 
Unanticipated Adverse Device Effect 
(UADE) 
Report within 2 calendar days 
Serious Adverse Event (SAE) / Serious 
Adverse Device Effect (SADE) 
Report within 2 calendar days  
 
The Investigator will report adverse events to the reviewing IRB/EC (as applicable) according 
to the applicable reporting requirements.  
 
The Sponsor is responsible for informing the relevant regulatory authorities and other 
investigators, according to applicable regulations, of any device or procedure-related SAE 
and/or UADE that has occurred. 
6.3 MEDICAL MONITOR REVIEW OF ADVERSE EVENTS 
Adverse events will be reviewed regularly by the Sponsor’s Medical Monitor and Clinical 
Advisors as required.   

 
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6.4  DEVICE DEFICIENCIES 
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety or performance.  
Note 1:  Device deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer, including labelling. 
Note 2:  This definition includes device deficiencies related to the investigational medical 
device. 
Should a device failure occur, it is essential that the device is returned to the study Sponsor 
for assessment of the device and the nature of the failure.   
6.5 DEVICE MALFUNCTION 
A device malfunction is defined as failure of an investigational medical device to perform in 
accordance with its intended purpose when used in accordance with the instructions for use 
or Clinical Investigation Plan or Investigator Brochure. 
6.6 USE ERROR 
Use error is defined as user action or lack of user action while using the medical device that 
leads to a different result than that intended by the manufacturer or expected by the user. 
 
Note 1:  Use error includes the inability of the user to complete a task. 
Note 2:  Use errors can result from a mismatch between the characteristics of the user, user 
interface, task or use environment. 
Note 3:  Users might be aware or unaware that a use error has occurred. 
Note 4:  An unexpected physiological response of the patient is not by itself considered a use 
error. 
Note 5:  A malfunction of a medical device that causes an unexpected result is not considered 
a use error. 
7 RISK AND BENEFITS 
7.1 POTENTIAL RISKS 
The risks of undergoing a vasectomy will be discussed with the subject by the Investigator 
and are separate from the intent of this study.  The potential risks to subjects participating in 
the clinical investigation are similar to those for a vasectomy and include the following: 
 
• Bleeding or a blood clot (hematoma) inside the scrotum 
• Blood in the semen 
• Bruising of the scrotum 
• Infection 

 
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• Mild pain or discomfort 
• Swelling 
• Allergic reaction 
• Inflammation caused by leaking sperm (granuloma) 
• An abnormal cyst (spermatocele) that develops in the small, coiled tube located on 
the upper testicle that collects and transports sperm (epididymis)  
• A fluid-filled sac (hydrocele) surrounding a testicle that causes swelling in the 
scrotum 
 
The DLAD could also result in the following: 
• Injury to the vas deferens 
• Nerve damage 
• Device fracture or dislodgment in the subject 
 
Infusion of saline into the lumen of the vas deferens in the direction of the bladder neck and 
urethra may result in the sensation of the urge to urinate.  Leakage of a small volume of saline 
out of the lumen of the vas deferens is expected to occur when vasectomy is performed 
following the DLAD procedure.  The leakage of saline is not expected to pose any 
additional risks to subjects as saline is widely used in medical procedures.  In the event of 
incorrect sheath placement, there is a risk that the 5.1 ml of saline may be delivered to 
non-target tissues/spaces, including the wall of the vas deferens, fascia, or other scrotal 
tissues.  This may result in temporary swelling, localized edema, and pain, though the 
saline is likely to drain out once the vas is cut for the vasectomy.  The risk of misplacement 
is very low due to risk mitigation steps including the device warning not to advance the 
DLAD guidewire against resistance.  When injecting the 5cc of saline, the physician is 
advised to inject saline slowly and stop if resistance is felt while depressing the 5cc syringe 
plunger.  
There may also be risks that are unanticipated at this time. 
7.2 MINIMIZATION OF ANTICIPATED RISKS 
Potential risks that may be associated with use of the DLAD have been minimized in this study 
by the following: 
a. Establishing eligibility criteria that exclude patients who are at higher risk for 
experiencing an anticipated adverse event; 
 
b. Conducting preclinical testing prior to the start of this trial;  
 

 
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c. Conducting a risk analysis and incorporating mitigations to eliminate and/or 
reduce risks to as low as reasonably practical (ALARP) in accordance with 
ISO 14971-Medical Devices – Application of risk analysis to medical devices. 
 
d. Providing detailed device labeling to help ensure proper device usage; 
 
e. Selecting investigators with proper level of training and experience; 
 
f. Ensuring physicians and staff receive adequate training; 
 
g. Closely monitoring subjects during the procedure; 
 
h. Ensuring adequate monitoring is performed to identify any safety issues associated 
with the study procedure and subjects; 
 
i. Regularly reviewing reported adverse events throughout the study and taking 
appropriate medical measures to resolve the adverse events. 
Further, to minimize the risk of anticipated adverse events, clinical study participation of an 
individual subject will be stopped if any of the following events are observed that could be an 
early signal of a possible safety event: 
• Inability to complete the intraluminal access confirmation; 
• Inability to deploy the DLAD; 
• Any condition that may impair the planned vasectomy of the study subject. 
7.3 POTENTIAL RISKS TO SUBJECT CONFIDENTIALITY 
In all clinical studies, confidentiality of protected health information may be breached due to 
study-related activities beyond those of routine clinical care.  This risk will be minimized by 
not collecting personally identifying information on Case Report Forms (CRFs) or other study 
related documentation and tests to be provided to the study Sponsor, as well as by obscuring 
subject protected health information (PHI). PHI will be replaced by a unique study number as 
per section 10.5 of this clinical investigational plan. 
7.4 POTENTIAL BENEFITS 
There is no direct benefit to study subjects.  The Subject’s participation in this research may 
add knowledge to the field of male contraception. 
8 STATISTICAL METHODOLOGY AND ANALYSIS  
All data collected for all enrolled subjects, referred to in ICH E9 (Statistical Principles for Clinical 
Trials) as the “full analysis set,” will be included in primary analyses of study outcomes. 
Continuous variables will be summarized with standard statistics including the mean, standard 
deviation, median and range or interquartile range. Categorical variables will be summarized 
using frequency tables and cross-tabulations. 

 
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For events that can occur more than once in a single subject, such as adverse events (AEs), the 
percentage will be based on the number of subjects experiencing the event; both subject and 
event counts will be reported. Listings of all adverse events will be provided along with summary 
tables. 
Data will be collected, tabulated and reported on all outcomes specified in this document as well 
as on baseline subject demographics, medical history, and other relevant characteristics. 
As the objective of this investigation is to evaluate DLAD product performance to inform 
elements of subsequent studies, sample size is not driven by formal evaluations of power against 
predefined success criteria and no formal statistical hypothesis testing will be used to evaluate 
such criteria. 
Statistical analyses will be performed in SAS version 9.4 or higher (SAS Institute, Cary, NC, USA) 
or R version 4.2 or higher (R Foundation for Statistical Computing, Vienna, Austria) or another 
validated statistical analysis package. 
9 DATA MONITORING AND QUALITY CONTROL 
All information and data concerning subjects or their participation in this study will be considered 
confidential.  Only authorized personnel will have access to this confidential information.  All data 
used in the analysis and reporting of this evaluation will be without identifiable reference to the 
subject. 
9.1 CASE REPORT FORMS (CRF) 
Electronic case report forms (eCRFs) specifically created for this study will be used to collect 
all subject data during the trial.  The Investigator or her/his designee is responsible for 
providing all data for the trial into the study eCRFs. All appropriate sections of the eCRFs must 
be completed.  This data should be entered within 5 business days of assessment. 
 
The Investigator must review and sign the eCRFs.  The Investigator is responsible for the 
accuracy and completeness of all data on the eCRFs. 
 
Sponsor personnel or designee will review completed eCRFs at the investigational site at 
regular intervals throughout the trial. Information on the eCRFs will be compared to 
information originally recorded on source documents related to the trial (i.e., professional 
notes, laboratory reports, etc.).  Information on the eCRF must match the same information 
on the source documents or an electronic data query will be issued.   
 
The Sponsor will use the study data for statistical and tracking purposes and will treat the 
information as confidential. 
9.2 DATA COLLECTION 
All required data for this trial will be collected on eCRFs. 
 
Qualified trial staff at the investigational site will perform primary data collection drawn from 
source document (e.g., medical/hospital chart) review.  The Sponsor monitors and/or 
designees will perform clinical trial monitoring of 100% of the subjects that pass screening 

 
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evaluations and undergo the DLAD procedure.  This monitoring will include review of eCRF 
data with verification to the source documentation. 
 
All eCRFs will be reviewed for completeness, validity, and consistency.  Queries will be 
generated and resolved with the sites and all protocol deviations will be recorded on the 
eCRF.  
9.3 MONITORING OF CLINICAL SITES AND INVESTIGATORS 
If the Sponsor determines that an Investigator is not in compliance with any requirements 
outlined in this investigational plan or the investigator agreement, the Sponsor shall promptly 
secure compliance or discontinue shipment of the investigational device.  
 
In addition, assessments including overall compliance with the investigational plan, accurate 
eCRFs, and compliance with Good Clinical Practices (GCP), IRB/ECs and applicable regulatory 
requirements will be monitored on an ongoing basis by the Sponsor and/or its designees. 
 
Periodic monitoring visits will be made at the investigational site throughout the clinical trial 
to ensure that the Investigator obligations are fulfilled, and all applicable regulations and 
guidelines are being followed.  These visits will ensure that the facilities are still acceptable, 
the investigational plan is being followed, the IRB/EC and applicable authorities have been 
notified of approved investigational plan changes as required, complete records are being 
maintained, appropriate and timely reports have been made to the Sponsor and/or its 
designees and the IRB/EC, device and device inventory are controlled and the Investigator is 
carrying out all agreed upon activities.  The Sponsor will reserve the right to remove either 
the Investigator or the investigational site from the trial for noncompliance with the 
investigational plan or regulations. 
 
10 STUDY MANAGEMENT AND RESPONSIBILITIES 
10.1 SPONSOR RESPONSIBILITIES 
The Sponsor has the overall responsibility for the conduct of the study according to Good 
Clinical Practice Guidelines and all applicable regulatory requirements.  For this study, the 
Sponsor will have certain direct responsibilities and may delegate other responsibilities to 
appropriate consultants and contract research organizations (CROs).  Together, the Sponsor, 
consultants and CROs will ensure that the study is conducted according to applicable 
regulations.  All personnel participating in the conduct of this clinical trial will be qualified by 
education and/or experience to perform their tasks. 
 
Specifically, the Sponsor has the overall responsibility of the study and will ensure the 
following activities are conducted: 
 
a) Select qualified monitors, investigators and contract research personnel 
b) Provide the Investigational Plan and any subsequent amendments to the study site 

 
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c) Provide appropriate information and device training to Investigators and study site 
staff 
d) Ensure that all deviations from the Investigational Plan are reviewed with the 
appropriate Investigator(s) and reported in the eCRF and the final report; also 
ensure that any necessary preventative or corrective action is taken 
e) Ensure that all adverse events and all adverse device effects are reported and 
reviewed with the Investigator(s), and where appropriate, that all serious adverse 
events and all serious adverse device effects and unanticipated adverse device 
effects are reported to the relevant authorities and IRB/EC 
f) Promptly inform the Investigators and, where applicable, any regulatory 
authorities and IRB/EC, if the study is prematurely terminated or suspended and 
the reason for the termination or suspension 
g) Ensure proper device usage, uniform data collection and protocol compliance 
h) Provide protocol initiation training to include review of the investigational device 
instructions for use, the protocol, eCRF instructions, and guidelines for obtaining 
informed consent 
i) Provide the study device and all necessary components to the study center, in 
quantities to support study activities 
j) Coordinate ongoing communication with CRO(s), consultants and the study center 
to resolve any problems concerning the protocol or data collection.  Every effort 
will be made to ensure compliance with the protocol 
k) Retain ownership of all clinical data generated in this study, and control the use of 
the data for purposes of regulatory submissions  
l) Protect subject confidentiality  
m) Collect, store and keep secure the following documents: 
• A current, signed and dated Curriculum Vitae of each Investigator 
• A copy of the current licensure of the Investigator 
• A signed and dated copy of the Investigator Agreement  
• A signed financial disclosure statement 
• The IRB/EC opinion and / or approval, in writing, and relevant correspondence 
• Correspondence with authorities (as required) 
• Appropriate insurance certificates (as necessary) 
• IRB/EC and regulatory authority approved informed consent form 
• Records of any adverse events and adverse device effects 
• Annual, Interim and Final report(s), as applicable 

 
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10.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for ensuring that the clinical study is conducted according to 
the Investigator Agreement, Investigational Plan, all conditions of national regulatory 
requirements, the IRB/EC, and in accordance with the highest standards of medical and good 
clinical practice (GCP), and the Declaration of Helsinki. 
 
The Investigator(s) shall be responsible for the day-to-day conduct of the investigation as well 
as for the safety and well-being of the human subjects involved in the clinical investigation.  
The Investigator(s) shall: 
 
a) Have the resources to conduct the investigation properly 
b) Obtain from the Sponsor the information which the Investigator(s) judges essential 
about the device and be familiar with this information 
c) Be well acquainted with the protocol before signing it 
d) Support the monitor, auditor, if applicable, in their activities to verify compliance 
with the protocol, to perform source data verification and to correct the eCRFs 
where inconsistencies or missing values are identified 
e) Discuss with the Sponsor management any question or proposed modification of 
the protocol 
f) Make sure that the protocol is followed by all responsible for the conduct of the 
study at his/her institution.  Any deviation shall be documented and reported to 
the study Sponsor. 
g) Make the necessary arrangements to ensure the proper conduct and completion 
of the investigation 
h) Make the necessary arrangements for emergency treatment, as needed, to protect 
the health and welfare of the subject 
i) Ensure that appropriate IRB/EC approvals are obtained prior to the start of the 
investigation 
j) Provide the communication from the IRB/EC to the study sponsor 
k) Inform the IRB/EC about any serious adverse device effects in accordance with the 
IRB/EC requirements. 
l) Inform the Sponsor about any adverse events and adverse device effects in a 
timely manner and in accordance with the timelines laid out in this protocol 
m) Endeavor to ensure an adequate recruitment of subjects 
n) Ensure that the subject has adequate time and information to give informed 
consent 
o) Ensure that informed consent is obtained and documented prior to any study 
specific evaluations or procedures being performed 

 
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p) Ensure that clinical records are clearly marked to indicate that the subject is 
enrolled in this study 
q) Provide subjects with well-defined procedures for any emergency and safeguard 
the subject’s interest 
r) Ensure that information which becomes available as a result of the clinical 
investigation which may be of importance to the health of a subject and the 
continuation of the investigation shall be made known to: 1) the Sponsor; 2) the 
subject; and 3) the subject’s personal clinician (with the subject’s approval), if 
pertinent to the safety or well-being of the subject 
s) Inform the subject and/or the subject’s physician (with the subject’s approval) 
about any premature termination or suspension of the investigation with a 
rationale for study termination 
t) Have primary responsibility for the accuracy, legibility and security of all 
investigational data, documents and subject records both during and after the 
investigation 
u) Sign each subject’s eCRFs 
v) Be responsible for the supervision and assignment of duties at his/her study center 
w) Ensure that all investigational devices are accounted for (number of devices used, 
discarded and returned to the Sponsor) 
x) Disclose to the Sponsor sufficient accurate financial information to allow the 
Investigator to submit complete and accurate certification or disclosure 
statements, and update the information during the course of the investigation and 
for one year following the completion of the study 
y) Ensure that the Investigator discloses to the Sponsor if the Investigator has ever 
been associated with terminated research and the reason for such termination is 
provided 
z) Ensure that the Investigator discloses to the Sponsor if the Investigator has ever 
been barred from conducting or participating in clinical research 
10.3 ETHICAL CONSIDERATIONS 
The rights, safety and well-being of clinical investigational subjects shall be protected 
consistent with the ethical principles specified in the Declaration of Helsinki and local and 
national regulations.  This shall be understood, observed and applied at every step in this 
clinical investigation. 
 
It is expected that all parties will share the responsibility for ethical conduct in accordance 
with their respective roles in the investigation.  The Sponsor and the Investigator(s) shall 
avoid improper influence or inducement of the subject, monitor, the clinical Investigator(s) 
or other parties participating in or contributing to the clinical investigation. 

 
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10.4 INFORMED CONSENT 
All patients must provide written informed consent in accordance with applicable law and 
approved by the site’s IRB/EC and regulatory authority.  Each investigational site must provide 
the Sponsor or designee with a copy of the investigational site’s IRB/EC approval letter and 
the IRB/EC approved informed consent form as well as the corresponding approvals from the 
regulatory authority.  The Sponsor or designee must review and approve the IRB/EC approved 
informed consent form prior to any subject enrollment.  Each subject must sign their own 
IRB/EC approved and Sponsor approved informed consent form.  
 
The person obtaining the informed consent shall: 
 
• Avoid any coercion of, or undue influence of, subjects to participate 
• Not waive or appear to waive subject’s legal rights 
• Provide complete, detailed description of study events, procedures, follow up and 
costs/reimbursements using language that is non-technical and understandable to 
the subject  
• Ensure that the patient understands risks and responsibilities 
• Provide ample time for the subject to consider participation, answer any questions 
and ensure that satisfactory answers are provided 
• Include dated signatures of the subject and of the clinical investigator (as applicable) 
• Shall ensure that applicable requirements are met for witness signatures  
• Ensure that the patient understands the voluntary nature of participation 
• Ensure protection of the subject’s confidentiality  
• Provide a copy of the Consent Form signed by the subject and the person 
presenting the information for the subject to take home 
The process that leads to informed consent will be documented. 
10.5 SUBJECT CONFIDENTIALITY 
At all times throughout this study, all parties shall strictly observe the confidentiality of each 
subject’s health information.  All data shall be secured against unauthorized access.  Each 
subject participating in this study will be assigned a unique identifier.  All eCRFs will be 
tracked, evaluated, and stored using only this unique identifier. 
 
The Investigator will maintain a confidential study subject list identifying all enrolled subjects.  
This list will contain the assigned study subject’s unique identifier and name.  The Investigator 
bears responsibility for keeping this list confidential.  This list will not be provided to the study 
Sponsor and is only to be used at the study center. 
 
Monitors and auditors will have access to the study subject list and other personally 
identifying information of study subjects to ensure that data reported in the eCRFs 

 
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corresponds to the person who signed the consent form, and the information contained in 
the original source documents.  Such personal identifying information may include, but not 
limited to, the subject’s name, address, date of birth, gender, race and medical record 
number. 
 
Any source documents copied for monitoring purposes by the Sponsor or designee will be 
identified by using the assigned subject’s unique identifier and obscuring personal identifying 
data to protect subject confidentiality. 
10.6 SELECTION AND TRAINING OF CLINICAL SITES AND INVESTIGATORS 
The primary requirements of selecting an Investigator for this study are:  experience and 
adequate training, facilities and equipment, adequate patient volume, appropriate personnel 
and site research staff to support the conduct of the trial, and commitment to safety and 
adherence to the investigational plan. 
 
Throughout the conduct of the trial, the Sponsor and/or its designees will closely monitor 
each site for the following: 
 
• Compliance with the investigational plan 
• Meeting enrollment commitments 
• Accurate and timely submission of eCRFs and additional data 
• Compliance with ICH Good Clinical Practice (GCP) guidelines 
• Compliance with IRB/EC and applicable regulatory requirements 
10.7 SITE QUALIFICATION 
The Sponsor or its designee, prior to acceptance of the site into this study, will conduct a site 
qualification visit or phone contact.  The site qualification visit/contact will be scheduled to 
include time with the Principal Investigator, co-investigators, study coordinator, and other 
study personnel as available.  Areas of discussion include a review of personnel training, 
expertise, and prior government -regulated study experience, this study’s specific 
requirements for procedures and equipment, and a review of staffing and equipment 
availability and appropriateness. 
10.8 PRE-STUDY TRAINING 
On-site pre-study training of involved trial personnel is the responsibility of the Sponsor or its 
designee.  To ensure investigational plan and regulatory compliance and accurate data 
collection, site training will include a detailed review of this Clinical Investigational Plan, eCRF 
completion, monitoring logistics and regulatory requirements.  
 
Prior to study implementation, the Study Monitor will ensure that study personnel: 
• Have appropriate training, facilities, time, and willingness to comply fully with the 
study requirements. 

 
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• Submit this Investigational Plan to the IRB/EC for appropriate review and obtain 
written approval for the conduct of the study prior to the initiation of any subject 
enrollment into this study. 
• Maintain all study correspondence, this Investigational Plan, training 
documentation, and all related and required records on file at their facility. 
• Assume full responsibility for the study investigation at their individual medical 
practices, clinics, and medical facilities.  The Study Monitor will create a written 
report of the pre-study site visit.  Resolution of any concerns and/or completion of 
any appropriate study activities identified during the pre-study visit will be 
documented by the Study Monitor, discussed with the Sponsor and submitted to 
the Investigator.   
• Complete any training required by the IRB/EC regarding protection of human 
subjects. 
10.9 RECORD RETENTION 
All trial records and reports will remain on file for a minimum of two (2) years (or longer if 
applicable law or hospital administration requires) after the latter of the following two 
dates:  completion date of trial closure or the date that records are no longer required for 
purposes of supporting a marketing authorization for regulatory agencies.  Trial records 
should only be discarded upon written notification by the Sponsor.  All records and reports 
are subject to inspection at any time. 
10.10 MAINTAINING RECORDS 
The Sponsor and/or its designees will maintain copies of correspondence, data, shipment of 
devices, adverse device effects and other records related to the clinical trial.  The Sponsor will 
maintain records related to the signed Investigator agreements. 
10.11 DEVICE ACCOUNTABILITY 
The Sponsor, or designee, shall ship investigational devices only to qualified Investigators.  
The Investigator shall maintain adequate records of the receipt and disposition of all 
investigational devices.  The Investigator shall return any unused devices, opened or 
unopened, to the Sponsor or its designees when the trial has completed.  If there is a device 
deficiency, malfunction or device-related adverse event that requires investigation, used 
devices must be returned to the Sponsor.   
10.12 TRIAL CLOSEOUT 
Upon completion of the clinical trial (when all subjects enrolled have completed the last 
required visit and the eCRFs and queries have been completed), the Sponsor and/or its 
designees will notify all investigational sites of closeout.  All eCRFs, unused trial devices, and 
any unused trial materials and equipment will be collected and returned to the Sponsor 
and/or its designees.   

 
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10.13 AUDITS AND INSPECTIONS 
The Investigator will permit access to original medical records and provide all requested 
information if the Sponsor and/or its designees or national/international regulatory 
authorities initiate any audits or inspections.  In the case that it is a non-Sponsor initiated 
audit, the Investigator must contact the Sponsor as soon as possible after notification of 
intent to audit. 
10.14 PUBLICATION POLICY AND FINAL REPORT 
Prior to enrollment of the first subject, this study will be listed on ClinicalTrials.gov in 
accordance with the requirements of the International Committee of Medical Journal Editors 
(ICMJE). 
All information concerning this study that has not been previously published is considered 
the confidential property solely of NEXT Life Sciences Inc.  This information includes, but is 
not limited to, the protocol, workbooks, technical methodology, and resulting data.  This 
information shall not be disclosed to others without prior written consent from NEXT Life 
Sciences, Inc. and shall not be used except in the performance of this study. 
To allow for the use of the information derived from this study and to ensure compliance with 
current Federal Regulations (USA) and all applicable local regulations abroad, the Investigator 
is obliged to provide NEXT Life Sciences, Inc. with complete test results and all data developed 
from this study.  
A final report will be completed even if the study is prematurely terminated.  At the 
conclusion of the study, a multi-center abstract reporting the results will be prepared and 
may be presented at a medical association meeting(s).  A multi-center publication may also 
be prepared for publication in a reputable scientific journal.  The publication of results from 
any single center experience within the trial is not allowed until the aggregate study results 
have been published, unless there is written consent from the study Sponsor.   
 
NEXT Life Sciences, Inc. will have final approval authority on the proposed content of the multi-
center study manuscripts submitted for publication.