A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study
Conditions: Hernia, Hernia, Ventral, Pathological Conditions, Anatomical, Hernia, Abdominal
Sponsor: Integra LifeSciences Corporation

Integra LifeSciences Corporation 
 
T-GENVIH-003 study 
 
 
 
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Protocol Version: V1.0 dated  02AUG2023  
 
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A Prospective Analysis of the Use of Gentrix® 
Surgical Matrix for Soft Tissue Reinforcement in 
Ventral Hernia Repair as Long Term Follow Up to       
T-GENVIH-002 study 
 
 
 
Short Title: Gentrix Ventral Hernia Repair Long Term Follow Up study 
 
Protocol Number: T-GENVIH-003 
 
National Clinical Trial (NCT) Identified Number: 06034652 
 
Version Number:  V1.0 
 
02-August-2023 
 
 
 
Sponsor:  
Integra LifeSciences Corporation 
1100 Campus Drive, Princeton, New Jersey, 08540 
USA 
www.integralife.com  
 
 
 
Confidentiality Statement 
The information provided in this document is strictly confidential and may not be disclosed to 
parties other than clinical investigation staff, appropriate governmental and regulatory agencies 
and the Ethics Committee directly involved in this clinical investigation. All parties must 
understand that confidential information may not be disseminated further without prior written 
permission from Integra LifeSciences Corporation. 

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Contents 
Contents ................................................................................................................................... 2 
A. 
ABBREVIATIONS ......................................................................................................... 5 
B. 
REVISION HISTORY .................................................................................................... 6 
C. 
AUTHORIZED SIGNATORIES FOR THE SPONSOR .............................................. 7 
D. 
STUDY INVESTIGATOR AND SITE MEDICAL STAFF ........................................... 8 
E. 
STATEMENT OF COMPLIANCE BY THE INVESTIGATOR ................................... 9 
1 
Protocol Summary ........................................................................................................10 
1.1 
Protocol Synopsis ...................................................................................................10 
1.2 
Schedule of Data Collection Activities ..................................................................13 
2 
Introduction ...................................................................................................................14 
2.1 
Background .............................................................................................................14 
2.2 
Investigational Product Overview..........................................................................15 
2.2.1 Gentrix® Surgical Matrix (6-layer): ...........................................................................15 
2.2.2 Gentrix® Surgical Matrix Plus (8-layer): ...................................................................16 
2.2.3 Gentrix® Surgical Matrix Thick: .................................................................................17 
2.2.1 
Study Device Intended Purpose ....................................................................17 
2.2.2 
Study Device Contraindication .......................................................................17 
2.2.3 
Required Training and Experience ................................................................17 
2.2.4 
Device Accountability ......................................................................................18 
2.2.5 
Device Traceability ..........................................................................................18 
2.3 
Study & Design Rationale ......................................................................................18 
3 
Objectives and Endpoints ............................................................................................18 
3.1 
Primary Objective ...................................................................................................18 
3.2 
Safety Objective ......................................................................................................19 
3.3 
Primary Endpoint ....................................................................................................19 
3.4 
Secondary Endpoints .............................................................................................19 
4 
Study Design ................................................................................................................20 
4.1 
Overall Design ........................................................................................................20 
4.2 
Scientific Rationale for Study Design ...................................................................20 
4.3 
End of Study Definition Overview .........................................................................20 
5 
Study Population ..........................................................................................................20 
5.1 
Inclusion Criteria .....................................................................................................20 
5.2 
Exclusion Criteria ....................................................................................................20 
5.3 
Description of the site .............................................................................................21 
5.4 
Point of Enrollment & Enrollment Period ..............................................................21 
5.5 
Strategies for Recruitment .....................................................................................21 
5.6 
Risk/Benefit Assessment .......................................................................................21 
5.6.1 
Risks associated with Study device ..............................................................21 
5.6.2 
Risks Associated with Participation in the study and mitigation .................22 

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5.6.3 
Anticipated Clinical and device Benefits .......................................................22 
5.6.4 
Rationale of Risks/Benefits Ratio ..................................................................22 
6 
Study Assessments and Procedures .........................................................................22 
6.1 
Schedule of Data Collection ..................................................................................22 
6.1.1 
Eligibility/Consent ............................................................................................22 
6.1.2 
Visit 1 Questionnaire (CRF) ...........................................................................23 
6.1.3 
Adverse Events ...............................................................................................23 
6.1.4 
Defice Deficiencies ..........................................................................................23 
6.1.5 
Study Exit / Completion ..................................................................................23 
6.2 
Monitoring ................................................................................................................24 
7 
Safety Assessments and Reporting ...........................................................................24 
7.1 
Definitions ................................................................................................................24 
7.2 
Reporting of Safety Information ............................................................................26 
7.2.1 
Non-Reportable Event ....................................................................................26 
7.2.2 
Severity ............................................................................................................26 
7.2.3 
Causality ...........................................................................................................27 
7.2.4 
Foreseeable adverse events and anticipated adverse device effects .......29 
7.3 
Reporting Requirements ........................................................................................29 
7.3.1 
Reporting of AEs and SAEs ...........................................................................29 
7.3.2 
Reporting Device Deficiency ..........................................................................30 
7.3.3 
Regulatory Reporting and Timelines .............................................................32 
8 
Lost to follow up............................................................................................................33 
9 
Data-Management .......................................................................................................33 
9.1 
Methods for data collection and data entry ..........................................................33 
9.2 
Source Data Requirements ...................................................................................34 
9.3 
Confidentiality and Data privacy ...........................................................................34 
9.4 
Study Record Retention .........................................................................................35 
10 
Statistical Considerations ............................................................................................35 
10.1 
Statistical Hypotheses ............................................................................................35 
10.2 
Sample Size Determination ...................................................................................36 
10.3 
Populations for Analyses .......................................................................................36 
10.4 
Statistical Analyses ................................................................................................37 
10.4.1 
General Approach ...........................................................................................37 
10.4.2 
Measures to Minimize Bias: Randomization and Blinding ..........................37 
10.4.3 
Analysis of the Primary Endpoint(s) ..............................................................37 
10.4.4 
Analysis of the Secondary Endpoint(s) .........................................................37 
10.4.5 
Safety Analyses ...............................................................................................38 
10.4.6 
Baseline Descriptive Statistics .......................................................................38 
10.4.7 
Planned Interim Analyses ...............................................................................38 
10.4.8 
Sub-Group Analyses .......................................................................................38 

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10.4.9 
Tabulation of Individual participant Data .......................................................38 
10.4.10 Sensitivity Analyses ...........................................................................................38 
11 
Regulatory, Ethical, Compliance and Operational Considerations .........................38 
11.1 
Informed Consent and Informed Consent Process .............................................38 
11.2 
Protocol Amendment ..............................................................................................38 
11.3 
Protocol Deviations ................................................................................................39 
11.4 
Publication Policy ...................................................................................................39 
12 
References ....................................................................................................................40 
13 
APPENDIX I ..................................................................................................................41 
List of Figures 
Figure 1: Gentrix® Surgical Matrix (6-layer) .............................................................................. 16 
Figure 2 : Gentrix® Surgical Matrix Plus (8-layer) ..................................................................... 17 
Figure 3: Gentrix® Surgical Matrix Thick ................................................................................... 17 
List of Tables 
Table 1: Scheduled of Data Collection Activities ....................................................................... 13 
Table 2: List of AE Terms and Definitions ................................................................................. 24 
Table 3: List of Devices and SKU # ........................................................................................... 41 

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A. ABBREVIATIONS
The list below includes abbreviations utilized in this template. However, this list should 
be customized for each protocol (i.e., abbreviations not used should be removed and new 
abbreviations used should be added to this list). 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
ANCOVA 
Analysis of Covariance 
ASADE 
Anticipated Serious Adverse Device Effect 
CDC 
Centers for Disease Control and Prevention 
CIP 
Clinical Investigational Plan 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CONSORT Consolidated Standards of Reporting Trials 
CTA 
Clinical Trial Agreement 
CRF 
Case Report Form 
DD 
Device Deficiency 
EDC 
Electronic Data Capture 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
LOS 
Length Of Hospital Stay 
LSMEANS 
Least-squares Means 
LTFU 
Long Term Follow Up 
MedDRA 
Medical Dictionary for Regulatory Activities 
MIS 
Minimally Invasive Surgery 
NCT 
National Clinical Trial 
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SSI 
Surgical Site Infection 
SSO 
Surgical Site Occurrence 
SSOPI 
Surgical Site Occurrences Requiring Procedural Intervention 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Event 

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B. REVISION HISTORY
The table below is intended to capture changes of IRB/EC-approved versions of the protocol, 
including a description of the change and rationale. A Summary of Changes table for the current 
amendment is located in the Protocol Title Page. Procedures for amending this protocol can be 
found in the current SOPs. 
Version 
Date 
Description of Change 
Brief Rationale 

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C. AUTHORIZED SIGNATORIES FOR THE SPONSOR
Name, Position/Title 
Signature 
David Sheleheda 
Sr. Director, 
Global Clinical Operations 
D. Adam Young, PhD PMP
Director of Medical Affairs,
Tissue Technologies
Nicole Kotter 
Sr. Manager, 
Regulatory Affairs 
Karen Bartku 
Clinical Research Manager, 
Global Clinical Operations 
Laurence Tong 
Lead Clinical Data Manager, 
Global Clinical Affairs 
Weiwei Xu 
Sr. Biostatistician, 
Global Clinical Affairs 
D. STUDY INVESTIGATOR AND SITE MEDICAL STAFF
SignNow e-signature ID: 50aafb085e...
03-Aug-2023 13:27:48 UTC
David Sheleheda (Signer)
SignNow e-signature ID: c8f4539756...
03-Aug-2023 13:46:47 UTC
Karen Bartku (Signer)
SignNow e-signature ID: 29a94f3dde...
03-Aug-2023 14:30:59 UTC
Weiwei Xu (Signer)
SignNow e-signature ID: ca4e2febb8...
04-Aug-2023 12:58:42 UTC
Adam Young (Signer)
SignNow e-signature ID: cf015d6c9c...
04-Aug-2023 16:36:54 UTC
Laurence Tong (Signer)
SignNow e-signature ID: 1af883a482...
07-Aug-2023 16:27:26 UTC
Nicole Kotter (Signer)

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The list of the study investigator and other site medical staff along with their contact information 
can be found in the Trial Master File. 

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E. STATEMENT OF COMPLIANCE BY THE
INVESTIGATOR
This clinical investigation will be conducted in compliance with the current ISO 14155 guidelines 
and applicable regulatory requirements, including the Medical Device Regulation (MDR) 
2017/745 [AND/OR] United States (US) Code of Federal Regulations (CFR) applicable to clinical 
studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and other applicable national and 
regional regulatory requirements whichever provides the greater protection of the individual.  
This clinical investigation will not be initiated until approval has been obtained from the Ethics 
Committee(s) (and Regulatory Authority if applicable). Any additional requirements imposed by 
the Ethics Committee(s) (and Regulatory Authority if applicable) will be followed.  
No deviation from the clinical investigation plan will be implemented without the prior review and 
approval of the Ethics Committee(s) except where it may be necessary to eliminate an immediate 
hazard to a subject. In such case, the deviation will be reported to the Ethics Committee(s) as 
soon as possible.  
Investigator’s Statement 
By signing this document, I agree to conduct this clinical study in accordance with the design and 
specific provisions of this clinical investigation plan; modifications to the clinical investigation are 
only acceptable with a mutually agreed upon clinical investigation plan amendment as approved 
by the Sponsor and involved Ethics Committee(s).  
I agree to await Ethics Committee approval of the clinical investigation plan and informed consent 
form before initiating the clinical investigation, to obtain consent from subjects prior to their 
enrolment, to collect and record data as required by the clinical investigation plan and associated 
case report forms, and to maintain documents related to the clinical investigation for the period of 
time required. 
Confidential 
This document contains confidential information belonging to Integra ® LifeSciences Corporation. 
Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, I 
agree to hold such information in confidence and not to disclose it to others (except where 
required by applicable law), nor use it for unauthorized purposes.  
Investigator Name 
Investigator Signature 
Date 

 
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1 Protocol Summary 
1.1 Protocol Synopsis  
Title 
A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft 
Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow 
Up (LTFU) to T-GENVIH-002 study 
Short Title 
Gentrix Ventral Hernia Repair LTFU study 
Protocol Number 
T-GENVIH-003 
Study Description 
The purpose of this study is to collect additional safety data and 
demonstrate the performance of Integra Gentrix® Surgical Matrix for 
reinforcement of ventral hernia repairs from a sub-population of 
participants in the T-GENVIH-002 study, specifically those with 
laparoscopic or robotic repair. Prospective data will be collected and 
assessed for later post-operative surgical site events and 
complications in the post-operative period from the last timepoint of 
data collection in T-GENVIH-002 to present. 
Pre/Post-Market 
Post-Market  
Product(s) 
Gentrix® Surgical Matrix - (6-layer), - Plus (8-layer), and -Thick  
*Refer to APPENDIX I at the end of the protocol for product-specific Stock 
Keeping Units (SKUs) to be included in this study. 
Indications for Use 
Gentrix® Surgical Matrix is intended for implantation to reinforce soft 
tissue where weakness exists in patients requiring gastroenterological 
or plastic & reconstructive surgery. Reinforcement of soft tissue within 
gastroenterological and plastic & reconstructive surgery includes, but 
is not limited to, the following open or laparoscopic procedures: hernia 
(e.g., hiatal/ diaphragmatic) and body wall repair, colon and rectal 
prolapse repair, tissue repair, and esophageal repair. Gentrix® 
Surgical Matrix minimizes tissue attachment to the device in case of 
direct contact with viscera. 
Study Design 
Single-Arm, Prospective, Single-Center 
Study Rationale 
This study adds to the available data evaluating the safety and 
effectiveness of Gentrix® Surgical Matrix in ventral hernia repair, 
particularly in a real-world population and particularly in the sub-

 
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population of minimally invasive surgery (MIS) cases (i.e., 
laparoscopic and robotic) from the GENVIH-002 study. 
Primary Objective 
The primary objective of this study is to capture additional existing 
clinical performance data to confirm the continued performance of the 
Gentrix® Surgical Matrix over longer term. 
Safety Objective 
The safety objective is to capture existing Gentrix® Surgical Matrix 
Complication data in the longer term period post primary repair 
procedure, not previously reported in T-GENVIH-002 study. 
Gentrix® Surgical Matrix Complications are defined but not limited to: 
• 
Seroma 
• 
Abscess 
• 
Dehiscence 
• 
Hematoma 
• 
Wound necrosis 
• 
Ileus 
• 
Fistula 
• 
Delayed wound healing 
Primary Endpoint 
1. Incidence of clinically confirmed recurrence of the primary hernia 
to date, including not previously reported in T-GENVIH-002 study. 
Secondary 
Endpoints 
1. Incidence of self-reported recurrence (i.e., bulge) of the primary 
hernia to date, including not previously reported in T-GENVIH-003 
study. 
2. Incidence of Surgical Site Occurrences requiring Procedural 
Intervention (SSOPI) of the primary hernia repair to date, including 
not previously reported in T-GENVIH-002. 
3. Incidence of Surgical Site Occurrences (SSOs) of the primary 
hernia repair to date (seroma, abscess, dehiscence, hematoma, 
wound necrosis, ileus, fistula, delayed wound healing), including not 
previously reported in T-GENVIH-002 study. 
4. Incidence of Surgical Site Infections (SSIs) post primary hernia 
repair to date, including not previously reported in T-GENVIH-002 
study. 

 
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5. Incidence of reoperation requirement of the primary hernia repair 
to date, including not previously reported in T-GENVIH-002 study. 
Description of Study 
Intervention 
A one-off subject interview with questionnaire will include a series of 
patients who underwent abdominal wall reconstruction for a ventral 
hernia repair with Integra Gentrix® Surgical Matrix to date, including 
not previously reported in the T-GENVIH-002 study. 
Study Population 
Patients from the sub-population of minimally invasive surgical 
approach (e.g., laparoscopic or robotic) of the T-GENVIH-002 study. 
Inclusion Criteria 
1. Patient was a subject in the T-GENVIH-002 study and 
underwent minimally invasive (i.e., laparoscopic or robotic) 
abdominal wall reconstruction for a primary hernia using Integra 
Gentrix® Surgical Matrix.  
2. Subject has participated in the informed consent process and 
signed a study-specific informed consent document. 
3. Subject is fluent in US English or US Spanish language. 
4. Subject is willing to complete an e-consent and phone or in-office 
visit. 
Exclusion Criteria 
Not applicable. 
Description of 
Sites/Facilities 
Enrolling 
Participants 
One site located in the United States (US) will participate in this study. 
Study Duration 
Approximately three months. 
Study 
Visits/Schedule of 
Study Activities 
This prospective study specifically aims to collect data from the day 
of the primary hernia surgical repair procedure longer term post-
operatively to date, including not previously reported in T-GENVIH-
002 study.  
Data Collection 
Data will be collected via a phone visit and questionnaire 
administered by the study coordinator (or, in the alternative, an in-
office visit and questionnaire administered by the study coordinator) 
and entered into an electronic data capture system by the site. The 
following data will be collected on the Long Term Follow Up (LTFU) 
of the primary hernia repair.  

 
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Clinical Performance and Safety Evaluation:   
1. SSOPI 
2. SSO(s) 
3. SSI(s) 
4. Hernia Recurrence  
5. Reoperation(s) 
6. Adverse Event(s) 
Statistical Methods 
& Analyses 
Study outcomes will be summarized using descriptive statistics. 
Categorical variables will be summarized using frequencies and 
percentages. Continuous variables will be summarized using means, 
standard deviations, medians, quartiles, ranges, and numbers of 
observations. 
Statistical analysis will be based on data from all evaluable subjects 
meeting the eligibility criteria. 
 
1.2 Schedule of Data Collection Activities 
Table 1: Schedule of Data Collection Activities 
 
*Prospective Data Collection 
 Screening  
 Subject Visit 1 
Eligibility/Consent 
X 
 
Complete Case Report Form(s) 
X 
X 
¥Adverse Events  
X 
X 
 
  *May occur on separate days 
  ¥Primary hernia surgery 

 
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2 Introduction 
2.1 Background 
Ventral hernias are a type of abdominal hernias that can occur at any location along the vertical 
abdominal wall. Typically, these defects are acquired resulting from complications of a prior 
surgery, trauma, or natively weak points of the abdominal wall in some individuals. Obesity may 
contribute in large part to the weak points due to cyclic patterns of weight gain and loss. One in 
eight patients will develop an incisional hernia after abdominal surgery1. 
Ventral hernia repair is one of the most common surgical procedures performed in the United 
States. Every year there are approximately 350,000 repairs performed in the US with an estimated 
cost of $3.2 billion.2 Different patient populations require different solutions in order to make a 
repair as cost-effective and risk-averse as possible. 
Clinical evidence has shown that primary suture repair of a ventral hernia alone results in high 
recurrence rates (>50%), and that all incisional hernia repairs should be reinforced with surgical 
mesh.3,4 Despite this consensus, due to the large variety of surgical meshes available currently, 
there is a lack of consensus on the ideal material for each repair. Ventral hernia treatment 
decisions are typically tied to patient operative risk, symptomatic concerns, and potential clinical 
complications of the repair. 
Permanent synthetic mesh has been the standard of care in the reinforcement of simple, clean 
hernias due to its minimal cost and history of low recurrence.5,6 However, due to the inherent 
permanence, long-term complications such as product migration, contraction, erosion, and 
infection are common.5-8 In the complex hernia setting, synthetic materials may not be ideal due 
to the increased risks of surgical site occurrences (SSOs) and resulting recurrences.5-8 These 
complications can prove costly with each hernia recurrence and wound event estimated to cost 
an additional $44,000 and $85,000 respectively.9,10 Specifically, a mesh infection can cost up to 
$140,000 and may require explantation of the mesh altogether.10 
Biologically-derived materials, such as acellular dermal matrices, were developed for use in 
complex hernia repair to mitigate some of the risks seen with synthetic materials. However, long-
term study of these materials demonstrated a 31.8% recurrence rate and 36.6% wound infection 
rate at 18.2 months follow-up.11 
Approximately 74% of inpatient ventral hernia repairs are completed as open procedures. While 
this number is slightly lower for outpatient ventral hernia repairs (64%), this remains the 
predominant surgical approach12 likely for more complex cases. 

 
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Currently available biologically derived mesh options for reinforced repairs include a class of non-
dermal products including Gentrix® Surgical Matrix devices. 
This post-market clinical study is being conducted to characterize the performance and safety of 
Gentrix® Surgical Matrix -(6-layer), -Plus (8-layer) and -Thick devices in the repair of ventral 
hernias in patients between 22 years and 80 years old (inclusive) at the time they underwent 
abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during 
the time period post primary hernia surgical repair to date, not previously reported in T-GENVIH-
002, as a longer term follow-up of safety and performance data in the sub-population of minimally 
invasive surgical cases (i.e., laparoscopic and robotic). 
2.2 Investigational Product Overview 
Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness 
exists in patients requiring gastroenterological or plastic & reconstructive surgery. 
Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery 
includes, but is not limited to, the following open or laparoscopic procedures: hernia (e.g., 
hiatal/diaphragmatic) and body wall repair, colon and rectal prolapse repair, tissue repair, and 
esophageal repair. Gentrix® Surgical Matrix minimizes tissue attachment to the device in case of 
direct contact with viscera. 
The Gentrix® Surgical Matrix Device configuration includes the Gentrix® Surgical Matrix (6-
layer), Gentrix® Surgical Matrix Plus (8-layer), and the Gentrix® Surgical Matrix Thick. 
2.2.1 Gentrix® Surgical Matrix (6-layer): 
Gentrix® Surgical Matrix (6-layer) is composed of a porcine-derived extracellular matrix, also 
known as urinary bladder matrix. The device is supplied in a multilayer sheet configuration in 
sizes up to 10 cm x 15 cm and packaged in double peel-open pouches. The device is terminally 
sterilized using electron beam irradiation. 
 

 
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Figure 1: Gentrix® Surgical Matrix (6-layer) 
 
2.2.2 Gentrix® Surgical Matrix Plus (8-layer): 
Gentrix® Surgical Matrix Plus (8-Layer) is composed of porcine-derived extracellular matrix, 
also known as urinary bladder matrix. The device is supplied in a multilayer sheet configuration 
in sizes up to 10 cm x 15 cm and packaged in double peel-open pouches. The device is 
terminally sterilized using electron beam irradiation. 
 
 
 

 
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Figure 2 : Gentrix® Surgical Matrix Plus (8-layer) 
2.2.3 Gentrix® Surgical Matrix Thick: 
Gentrix® Surgical Matrix Thick is composed of a porcine-derived extracellular matrix, also 
known as urinary bladder matrix. The device is supplied in a multi-layer sheet configuration in 
sizes up to 30 cm x 40 cm and packaged in double peel-open pouches. The device is terminally 
sterilized using electron beam irradiation. Animal studies have shown device resorption in 
approximately 240 days. 
 
 
 
Figure 3 : Gentrix® Surgical Matrix Thick 
  
2.2.1 Study Device Intended Purpose 
The Gentrix® Surgical Matrix devices were used within label in this prospective study. There were 
no specific medical or surgical procedures involved in the use of the study devices, other than the 
standard of care. A full description of the medical and surgical procedures related to the Gentrix® 
Surgical Matrix devices is available in the Instructions for Use (IFU). 
2.2.2 Study Device Contraindication 
Patients with known sensitivity or allergy to porcine materials. 
2.2.3 Required Training and Experience 
Previously trained on the use of the devices, the investigator must have used the devices within 
label in this study. Integra LifeSciences Corporation did not train, nor dictate, the surgery 

 
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technique(s). The investigator must meet certain expectations per Sponsor Standard Operating 
Procedures (SOPs). 
2.2.4 Device Accountability 
No device accountability will be performed for the purposes of this study given the study is 
noninterventional. 
2.2.5 Device Traceability 
No device traceability will be performed for the purposes of this study given the study is 
noninterventional. 
2.3 Study & Design Rationale 
This is a single-arm, single-center, prospective study to collect in routine use additional safety 
data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of 
minimally invasive (i.e., laparoscopic and robotic) ventral hernia repairs as a LTFU of the T-
GENVIH-002 study. Routine use data to date – longer term, not previously reported -- will be 
collected prospectively at one site. This study adds to the available data evaluating the safety and 
effectiveness of Gentrix® Surgical Matrix in ventral hernia repair, particularly in a real-world 
population, and particularly in the sub-population described. 
 
3 Objectives and Endpoints 
3.1 Primary Objective 
The primary objective of this study is to capture existing clinical performance data to confirm the 
continued performance of the Gentrix® Surgical Matrix as a long term follow up (LTFU) to T-
GENVIH-002 study for minimally invasive surgical approach (laparoscopic and robotic) sub-
population of cases post primary hernia surgical repair to date, not previously reported in the T-
GENVIH-002 study. 
Existing clinical data support the safety and performance of the Gentrix® Surgical Matrix. There 
are currently no safety concerns with these products. This clinical investigation will confirm the 
safety and performance of the Gentrix® Surgical Matrix particularly in MIS cases and identify any 
unknown or not previously reported side-effects. 

 
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3.2 Safety Objective 
The safety objective of this study is to capture existing Gentrix Surgical Matrix Complication 
data in the later post-operative period  to date, not previously reported in the T-GENVIH-002 
study. 
Gentrix® Surgical Matrix Complications are defined but not limited to: 
• 
Seroma 
• 
Abscess 
• 
Dehiscence 
• 
Hematoma 
• 
Wound necrosis 
• 
Ileus 
• 
Fistula 
• 
Delayed wound healing 
3.3 Primary Endpoint 
The primary endpoint of this prospective study is to determine the incidence of clinically confirmed 
recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 
study. 
3.4 Secondary Endpoints 
1. Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not 
previously reported in T-GENVIH-003 study. 
2. Incidence of Surgical Site Occurrences requiring procedural intervention (SSOPI) of the 
primary hernia repair to date, not previously reported in T-GENVIH-002. 
3. Incidence of  Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, 
abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), 
including not previously reported in T-GENVIH-002 study. 
4. Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not 
previously reported in GENVIH-002 study. 
5. Incidence of reoperation requirement of the primary hernia repair to date, including not 
previously reported in GENVIH-002 study.  

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4 Study Design 
4.1 Overall Design 
The Gentrix Ventral Hernia Repair Long Term Follow Up study is a single-arm, prospective, 
single-center, post-market study which includes Long Term Follow Up (LTFU) safety and 
performance outcomes of a sub-population of subjects who underwent minimally invasive (e.g., 
laparoscopic or robotic) surgical repair using Gentrix® Surgical Matrix post index procedure to 
date, including not previously reported in T-GENVIH-002 study. 
4.2 Scientific Rationale for Study Design 
This study adds to the available data evaluating the safety and effectiveness of Gentrix Surgical 
Matrix in ventral hernia repair, particularly in a real-world population, and particularly in the MIS 
sub-population described. 
4.3 End of Study Definition Overview 
The end of the study is defined as completion of Case Report Forms (CRFs) for the last subject 
in this prospective study. 
 
5 Study Population 
5.1 Inclusion Criteria 
1. Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., 
laparoscopic or robotic) surgical abdominal wall reconstruction for a primary hernia repair using 
Integra Gentrix® Surgical Matrix. 
2.  Subject has participated in the informed consent process and signed a study-specific informed 
consent document. 
3.  Subject is fluent in US English or US Spanish language. 
4.  Subject is willing to complete an e-consent and phone or in-office visit. 
5.2 Exclusion Criteria 
Not applicable. 

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5.3 Description of the site 
One site in the US will be selected to participate in this study. The study site was selected based 
upon their prior  participation in the T-GENVIH-002 study, experience with the subject device, 
their clinical expertise, expected commitment to have available data for eligible study patients, 
and their ability to fulfill general requirements in the Sponsor’s SOPs and to comply with this 
protocol.  
5.4 Point of Enrollment & Enrollment Period 
The patients will  provide informed consent to allow use of their data. There is no traditional 
enrollment period in this study. Data will begin to be collected from the first patient who meets all 
the eligibility criteria. 
The total expected duration of the study is approximately 3 months. 
5.5 Strategies for Recruitment  
A one-off subject phone (call) visit will constitute the source of data and  will be collected using a 
study-specific eCRF delivered via a phone script by the site responsible or their designee(s). Each 
patient should be included in the study only once. Patient screening will rely on site identification 
and contact of prior T-GENVIH-002 study subjects (Sponsor remains blinded) and e-consent 
process. In these cases, every effort should be made to identify every possible eligible patient. 
For those that are lost to follow up, site may work directly with a Sponsor approved people search 
service (Sponsor remains blinded). In order to be eligible for the study, patients should meet all 
of the eligibility criteria. 
For subjects who decline an electronic consent collected remotely, an in-office interview and 
assistance with completing the electronic consent in person with the site study coordinator or their 
designee(s) will be offered for the convenience of the subjects and to maximize data collection 
efforts. 
5.6 Risk/Benefit Assessment 
5.6.1 Risks associated with Study device  
Complications and reactions are possible with any soft tissue repair, including but not limited to 
infection, increased chronic inflammation, allergic reaction, unexplained fever or chills, 
excessive redness, acute and chronic pain, swelling, tender scars, adhesions, seroma 
formation, fistula formation, hematoma, recurrence of tissue defect, delayed or failed 

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incorporation of graft, urinary or fecal incontinence, delayed or failed incorporation of graft 
(mesh) or suture erosion or extrusion, and injury to the bladder, bowel, blood vessels.  
5.6.2 Risks Associated with Participation in the study and mitigation 
As this prospective study involves data collection, there are only minimal risks associated with 
participation. There are no additional device-related risks for this study. There are, however, 
privacy (loss of confidentiality) risks associated with participation in the study. 
Participation in the study does not submit the patient to any additional procedures or exams 
outside the customary standard of care. Patient confidentiality and privacy is strictly held in trust 
by the participating investigator, their staff, and the Sponsor. The patient’s data will be given a 
code to assure that the data can only be traced with the use of an identifier. The identifier will be 
stored securely in the local research institute. Data that is shared with the sponsor will only contain 
the code. The patient’s name and any other identifiable information will be omitted. All national 
data protection laws will be respected including the US Health Insurance Portability and 
Accountability Act of 1996 (HIPAA). Data shared with the Sponsor will be encoded and maintained 
in a secure electronic database that is compliant with 21 CFR Part 11 requirements on electronic 
records and electronic signatures.  
5.6.3 Anticipated Clinical and device Benefits  
There is no direct benefit. Information learned from this study might help researchers to better 
understand medical treatments and disease processes or procedures in order to better help 
others in the future.  
The data collected from the study will be used to inform the device manufacturer about the safety 
and performance of the device when used in accordance with the device labelling.  
5.6.4 Rationale of Risks/Benefits Ratio 
The participation in the study does not add risks to the patients, thus the benefit is judged to 
outweigh the overall residual risks. 
6 Study Assessments and Procedures 
6.1 Schedule of Data Collection 
6.1.1 Eligibility/Consent 
• The procedures to be completed are: 

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 Identification of the full consecutive series of patients who underwent abdominal wall 
reconstruction for a minimally invasive surgical approach (i.e., laparoscopic or robotic) 
hernia with Integra® Gentrix® Surgical Matrix from the prior T-GENVIH-002 study and 
informed consent for those who volunteer to participate. 
 Creation on the CRF of a new case book for each eligible subject. Each created case book 
assigns the eligible subject with a study number. 
 Completion of Worksheets/ CRFs: Site will transcribe/transmit the below-mentioned 
patients’ data in study CRFs. The patients’ data will originate from a direct interview with 
the subject by the study coordinator. 
• The patients’ data to be collected are: 
 Eligibility: 
o Inclusion Criteria: Ensure the subject meets all the inclusion criteria. 
6.1.2 Visit 1 Questionnaire  
The patients’ data to be collected from the last data collection of GENVIH-002 study to date, 
including not previously reported, are: 
• Clinically confirmed recurrence of the primary hernia repair 
• Self-reported recurrence (i.e., bulge) of the primary hernia 
• Surgical Site Occurrences requiring Procedural Intervention (SSOPI) 
• Surgical Site Occurrences (SSOs) 
• Surgical Site Infections (SSIs) 
6.1.3 Adverse Events 
Information will be collected on post-operative adverse events that relate to the primary hernia 
repair procedure, including those not  previously reported in the T-GENVIH-002 study.  
6.1.4    Device Deficiencies 
Information will be collected for post-operative device deficiencies that relate to the primary 
hernia repair procedure, including those not previously reported in the T-GENVIH-002 study. 
6.1.5    Study Completion/Exit 
Information will be collected by the study coordinator for each enrolled subject to reflect study 
exit type. 

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6.2 Monitoring  
Monitoring of the study may be conducted either remotely or in-person, as determined by the 
Sponsor per Sponsor’s Monitoring Visit Plan. 
7 Safety Assessments and Reporting 
7.1 Definitions 
The table below contains the definitions being used for safety assessment as part of this study: 
 
 
Table 2: List of AE Terms and Definitions  
This list of terms should be edited to remove those which do not concern the study. 
Term 
Definition 
Adverse Device 
Effect (ADE) 
 
An adverse event related to the use of an investigational medical 
device. This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device. And this definition includes any event 
resulting from use error or from intentional misuse of the 
investigational device. 
Adverse Event (AE)  
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users, or other persons, whether or not related to the 
investigational medical device and whether anticipated of 
unanticipated.  
This definition includes events related to the investigational medical 
device; events related to the procedures involved and, for users or 
other persons, this definition is restricted to events related to 
investigational medical devices. 
Anticipated Serious 
Adverse Device 
Effect (ASADE) 
A serious adverse device effect which by its nature, incidence, 
severity or outcome has been identified in the risk assessment 

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This list of terms should be edited to remove those which do not concern the study. 
Term 
Definition 
Device Deficiency 
(DD) 
 
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 or the comparator.  
Malfunction 
 
Failure of an investigational medical device to perform in accordance 
with its intended purpose when used in accordance with the 
instruction for use. 
Serious Adverse 
Device Effect (SADE)  
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.  
Note: SAEs related to procedures imposed by the clinical 
investigation plan but not with the use of the device should not be 
considered Serious Adverse Device Effects. 
Serious Adverse 
Event (SAE) 
 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other 
persons as defined by one or more of the following: 
a life-threatening illness or injury, or 
a permanent impairment of a body structure or a body function 
including chronic diseases, or 
in-patient or prolonged hospitalization, or 
medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
c) fetal distress, fetal death or a congenital abnormality or birth defect 
including physical or mental impairment. 
Note: Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in health, 
is not considered a serious adverse event.  

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This list of terms should be edited to remove those which do not concern the study. 
Term 
Definition 
Unanticipated 
Adverse Device 
Effect (UADE) 
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. 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
 
Serious adverse device effect which by its nature, incidence, severity 
or outcome has not been identified in the current risk assessment.  
Note 1: Anticipated serious adverse device effect (ASADE) is an 
effect which by its nature, incidence, severity or outcome has been 
identified in the risk assessment.  
Note 2: Procedures associated with the use of a device should be 
addressed in the risk assessment, which makes it possible to 
determine whether the procedure related SAEs are Unanticipated 
Serious Adverse Device Effect or not.  
 
7.2 Reporting of Safety Information 
7.2.1 Non-Reportable Event 
Adverse Events not related to the primary hernia repair procedure will not be required to be 
reported by the investigator in this study. 
7.2.2 Severity 
Each adverse event will be classified according to three (3) levels of severity. The Sponsor and 
the investigator will use the following definitions to assess the severity of the adverse event:  
 
Mild – Awareness of signs or symptoms, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Symptoms do not require therapy or a 
medical evaluation; signs and symptoms are transient.  
Moderate – Events introduce a low level of inconvenience or concern to the participant 
and may interfere with daily activities but are usually improved by simple therapeutic 
measures; moderate experiences may cause some interference with functioning.  

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Severe – Events interrupt the participant’s normal daily activities and generally require 
systemic drug therapy or other treatment; they are usually incapacitating.  
7.2.3 Causality 
The relationship between the use of the medical device (including the medical - surgical 
procedure) and the occurrence of each adverse event shall be assessed and categorized. 
Each AE will be classified according to four (4) different levels of causality: 
Not related: Relationship to the device, or procedures can be excluded when: 
• 
the event has no temporal relationship with the use of the study devices, or the procedures 
related to application of the study devices; 
• 
the serious adverse event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
• 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of 
the level of activation/exposure), do not impact on the serious adverse event; 
• 
the event involves a body-site or an organ that cannot be affected by the device or 
procedure; 
• 
the serious adverse event can be attributed to another cause (e.g., an underlying or 
concurrent illness/ clinical condition, an effect of another device, drug, treatment or other 
risk factors);  
• 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable;  
In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event. 
Possible: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g., an underlying or concurrent illness/ clinical condition or/and an effect of 
another device, drug or treatment). Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
Probable: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably explained 
by another cause. 

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Causal relationship: The serious adverse event is associated with the investigational device, or 
with procedures beyond reasonable doubt when:  
• 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
• 
the event has a temporal relationship with investigational device use/application or 
procedures;  
• 
the event involves a body-site or organ that 
o the investigational device or procedures are applied to;  
o the investigational device or procedures have an effect on;  
• 
the serious adverse event follows a known response pattern to the medical device (if the 
response pattern is previously known);  
• 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse event (when clinically feasible); 
• 
other possible causes (e.g., an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment) have been adequately ruled out; 
• 
harm to the subject is due to error in use; 
• 
the event depends on a false result given by the investigational device used for diagnosis, 
when applicable;  
In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event. 
The Sponsor and the investigator will distinguish between the adverse events related to the study 
device and those related to the procedures (any procedure specific to the study). An adverse 
event can be related both to procedure and the study device.  
During causality assessment activity, clinical judgement shall be used and the relevant 
documents, such as the IFU, the Clinical Investigation Plan or the Risk Analysis Report shall be 
consulted, as all the foreseeable serious adverse events and the potential risks are listed and 
assessed there. The presence of confounding factors, such as concomitant medication/treatment, 
the natural history of the underlying disease, other concurrent illness or risk factors shall also be 
considered. 
Complications caused by concomitant treatments not imposed by the clinical investigation plan 
are considered not related. Similarly, several routine diagnostic or patient management 
procedures are applied to patients regardless of the clinical investigation plan. If routine 

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procedures are not imposed by the clinical investigation plan, complications caused by them are 
also considered not related.  
In some particular cases the event may not be adequately assessed because information is 
insufficient or contradictory and/or the data cannot be verified or supplemented. The Sponsor and 
the investigator will make the maximum effort to define and categorize the event and avoid these 
situations. Where an investigator assessment is not available and/or the Sponsor remains 
uncertain about classifying the adverse event, the sponsor should not exclude the relatedness; 
the event should be classified as “possible” and the reporting not be delayed. Particular attention 
shall be given to the causality evaluation of unanticipated serious adverse events. The occurrence 
of unanticipated events related to the use of the device could suggest that the clinical investigation 
places subjects at increased risk of harm than was to be expected beforehand. 
7.2.4 Foreseeable adverse events and anticipated adverse device effects 
The following adverse events are outlined, and therefore anticipated, in the device’s Instructions 
for Use (IFU): 
Infection, increased chronic inflammation, allergic reaction, unexplained fever or chills, 
excessive redness, acute and chronic pain, swelling, tender scars, adhesions, seroma 
formation, fistula formation, hematoma, recurrence of tissue defect, anastomotic stricture 
formation and leaks, dyspareunia, vaginal shortening, vaginal bleeding, atypical vaginal 
discharge, groin and/or buttock and/or leg pain, urinary or fecal incontinence, delayed or failed 
incorporation of graft, failure to repair a prolapse, recurrent prolapse, mesh or suture erosion or 
extrusion, and injury to the bladder, bowel, blood vessels, and/or nerves of the pelvis. 
7.3 Reporting Requirements 
7.3.1 Reporting of AEs and SAEs 
The investigator will determine if there has been a potentially device or procedure related adverse 
event or potentially device or procedure related serious adverse event. All potentially device or 
procedure related adverse events and potentially device or procedure related serious adverse 
events must be reported on the “Adverse Event” form. 
Potentially device or procedure related adverse events and potentially device or procedure related 
serious adverse events will be evaluated and differentiated by:  
• 
Seriousness of the event;  
• 
Causality of the event (in relation to the device or procedure);  

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• 
Severity of the event. 
All potentially device or procedure related AEs and potentially device or procedure related SAEs 
must be collected for all enrolled subjects starting from the time of enrollment through the last 
Follow-up. Each AE must be described as follows: 
 
AE Term: A medically defined diagnosis/symptom. Use the highest level of evidence 
available. 
Level 1: Diagnosis (highest level) 
Level 2: Symptoms 
Level 3: Signs (lower level) 
 
AE Description: Explain the circumstance of becoming aware of the event, how the subject 
explained the circumstances surrounding the onset of the event, the underlying cause (the 
diagnosis), coexisting disease, or other condition or complaint involving the event. 
 
AE Duration: Document by entering the date of onset (start date) and date of resolution (stop 
date). 
 
AE Causality: Document causal relationship between event and the investigational product 
and Study Procedure (causally related, possible, probably, not related). 
 
AE Seriousness: Document as serious or not serious.  
 
AE Severity: Document as mild (transient and easily tolerated by the subject), moderate 
(discomfort and interrupts normal activities), or severe (incapacitating with inability to work or 
do usual activity). 
 
Action(s) Taken and/or Treatment(s): Document as none, medication, hospitalization, 
surgical, and/or other. Any prescribed medication should be noted in the subject’s medical 
records and transcribed onto the AE and Concomitant Medications CRFs. If a surgical or 
invasive procedure is required for an AE, document the procedure on the Invasive Procedure 
Log. 
 
Outcome: Document as recovered without sequelae, recovered with sequelae, ongoing, 
death, or other. AEs will be followed until a resolution has occurred, until a resolution is no 
longer expected, the pre-existing condition returns to baseline conditions, or the subject exits 
the study. 

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7.3.2 Reporting Device Deficiency 
All device deficiencies (DDs) related to the identity, quality, durability, reliability, usability, safety 
or performance of the study device including the analysis of used or explanted study device, 
where applicable, shall be documented throughout the study and managed by the sponsor.  
The principal investigator shall record every observed device deficiency on the “Device 
Deficiency” form, together with an assessment for all enrolled subjects starting from the time of 
enrollment through the last Follow-up visit. Each DD must be described as follows: 
 
Deficiency Type:  
• 
Identity (Packaging/Labeling)  
• 
Quality (Structure/Appearance)  
• 
Durability (ability to withstand wear, pressure, or damage)  
• 
Usability (use error, misuse, abnormal use)  
• 
Reliability (Performs in a consistent manner)  
• 
Safety (Impact on Patient Care)  
• 
Performance (Functions according to the IFU)  
 
When the deficiency was noted 
 
If the deficiency was associated with an AE 
 
If the deficiency might have led to: 
• Adverse Effect 
• Serious Adverse Device Effect 
Device deficiencies shall be managed by the sponsor in accordance with written procedures for 
the control of non-conforming product. The sponsor shall take appropriate corrective and 
preventive actions to protect the safety of subjects, users and other persons. 
In case of DD that could have led to SADE, the sponsor determines whether the risk analysis 
needs to be updated and assess whether corrective or preventive action is required. 
The Site should make every attempt to save or collect the defective device, and if appropriate, 
the packaging, for return to the Sponsor. A qualified company representative will investigate and 
determine root cause and corrective actions as applicable, and directives will be provided to the 
site if warranted. 
If the site documents a DD, the site will report the event in accordance with the following 
parameters. It should be noted that no documents should be submitted to any regulatory 

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agency without communicating with the Sponsor beforehand to assure accuracy and 
completeness of the information. 
For DDs, the principal investigator shall:  
• 
report to the sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect and documented in the 
AE CRFs as noted above, 
• 
report to the IRB/EC device deficiencies that could have led to a serious adverse device 
effect, if required by the national regulations or by the IRB, 
• 
report to regulatory authorities device deficiencies that could have led to a serious adverse 
device effect, as required by the national regulations, and 
• 
supply the sponsor, upon sponsor's request, with any additional information related to the 
safety reporting of a particular event. 
Device deficiencies that did not lead to an adverse event but could have led to a medical 
occurrence: 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate, 
shall be reported as specified as stated below. 
Device deficiencies shall be managed by the sponsor in accordance with written procedures for 
the control of non-conforming product. The sponsor shall take appropriate corrective and 
preventive actions to protect the safety of subjects, users and other persons. 
For DDs, the sponsor shall: 
• 
report or ensure the reporting, to the IRB by the principal investigator(s), of all serious 
adverse events and device deficiencies that could have led to a serious adverse device 
effect, if required by national regulations or by the IRB, 
• 
report to regulatory authorities, within the required time period, all serious adverse events 
including serious health threat and device deficiencies that could have led to a serious 
adverse device effect, if required by national regulations or the CIP, 
• 
report all relevant safety information to the DMC, if established, according to written 
procedures. 
7.3.3 Regulatory Reporting and Timelines 
• 
Report by the Investigator to the Sponsor  

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The sponsor shall implement and maintain a system to ensure that the reporting of the 
reportable events as defined under Section 7.2.1 Non-Reportable Event will be provided by the 
investigator to the sponsor immediately, but not later than 5 calendar days after investigation 
site study personnel’s awareness of the event. 
• 
Report to the IRB  
Prior to initiation of the study, reporting requirements of AEs and DDs for the IRB will be verified 
and documented. Reporting will occur according to the requirements set forth by the involved 
IRB and/or national requirements. 
8 Lost to follow up 
A participant will be considered lost to follow up if not able to be contacted and/or not responsive. 
Site will conduct a due diligence attempt per site standard operating procedures. A person search 
vendor approved by the Sponsor may be  utilized by the site to find latest contact information for 
subjects on an as needed basis (Sponsor remains blinded to this activity). The site will document 
these proceedings for local records and complete the Sponsor’s Study Completion/Exit Form. 
 
9 Data Management 
 
9.1 Methods for data collection and data entry 
An EDC system which is a 21 CFR Part 11-compliant data capture system with eCRF designed 
and the study database built will be used for the purposes of this clinical investigation. The data 
entered into  the EDC system will be  reviewed and cleaned. Queries will be issued to the site via 
the EDC system and are to be resolved by the investigator or his designee using the EDC system. 
An audit trail in the system is available for tracking all information including the site user enters, 
modifies, or deletes the study data and query resolution. 
Data review and data cleaning will be completed on a regular basis. The study data will be 
reviewed and cleaned to ensure that there are no outstanding data discrepancies prior to 
database lock. Any changes to the database after that time will require written agreement by 
Integra LifeSciences Corporation.  
A Data Management Plan is prepared to document precisely the procedures for the study 
database development, data review, data cleaning and query resolution. 

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information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
9.2 Source Data Requirements 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
The investigator or its delegate will perform primary data collection drawn directly from the subject 
by use of an interview (either by phone or in-person) by the study coordinator, using a paper Case 
Report Form that the coordinator will fill out. Source data is defined as all information in original 
records, certified copies of original records of clinical findings, observations, or other activities in 
a clinical investigation, necessary for the reconstruction and evaluation of the clinical 
investigation. All source documents should be completed in a neat, legible manner to ensure 
accurate interpretation of data. In this study, the Case Report Form is a Source Document.  
Clinical data (including adverse events (AEs) will be entered into EDC system, a 21 CFR Part 11-
compliant data capture system, provided by the Sponsor. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that 
appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source documents. 
The investigator shall ensure the accuracy, completeness, legibility, and timelines of the data 
reported in CRF and in all required documentation. Data reported on the CRF shall be supported 
by the source documents with any discrepancies being explained. Any corrections made to 
documents will be done according to ISO 14155 guidelines. If an item is not available or is not 
applicable, this fact should be indicated; no space is to be left blank. The investigator who has 
signed the clinical investigation plan signature page or his/her authorized designee is to 
personally sign the CRFs to validate that the observations and findings are recorded on the 
eCRFs correctly and completely. The CRFs are to be completed in a timely manner after the 
subject’s visit. Failure to meet the documentation requirements may lead to the disqualification of 
an investigator.  
9.3 Confidentiality and Data privacy 
Participant confidentiality and privacy is strictly held in trust by the participating investigator, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover testing 
of biological samples and genetic tests in addition to the clinical information relating to 
participants. Therefore, the study protocol, documentation, data, and all other information 

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T-GENVIH-003 study 
 
 
 
Confidential 
Protocol Version: V1.0 dated  02AUG2023  
 
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This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential 
information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
generated will be held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), or regulatory agencies may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records. 
The study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, Institutional policies, or sponsor 
requirements. 
9.4 Study Record Retention 
The Principal Investigator and Integra LifeSciences will maintain accurate, complete, and current 
records relating to participation in this study. If the Principal Investigator wishes to assign the 
responsibility of maintaining the study files to someone else or move them to another location, 
he/she should consult with Integra LifeSciences in writing regarding the change. The Principal 
Investigator will take measures to ensure that these essential documents are not accidentally 
damaged or destroyed.  
Upon study completion, the investigator on one hand and Integra LifeSciences on the other hand 
will maintain all study records for the minimum time required by the US law and regulation and in 
accordance with 21 CFR 812, Subpart G. 
 
10 Statistical Considerations  
The detailed analyses methods will be described in the Statistical Analyses Plan (SAP). 
10.1 Statistical Hypotheses 
This is a prospective, single-arm, single center post-market study to capture existing clinical 
performance data to confirm the continued performance of the Gentrix® Surgical Matrix. A 
formal hypothesis does not apply to this study. Subjects from that consecutive series will be 
included in the study based on the defined inclusion and exclusion criteria. 

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This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential 
information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
Primary Endpoint(s):  
The primary endpoint of this prospective study is to determine the incidence of clinically confirmed 
recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 
study. 
 
Secondary Endpoint(s): 
1. Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not 
previously reported in T-GENVIH-003 study. 
2. Incidence of Surgical Site Occurrences  requiring Procedural Intervention (SSOPI) of the 
primary hernia repair to date, including not previously reported in T-GENVIH-002. 
3. Incidence of  Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, 
abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), 
including not previously reported in T-GENVIH-002 study. 
4. Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not 
previously reported in GENVIH-002 study. 
5. Incidence of reoperation requirement of the primary hernia repair to date, including not 
previously reported in GENVIH-002 study. 
10.2 Sample Size Determination 
Subjects from that consecutive series will be included in the study based on the defined inclusion 
and exclusion criteria. The planned sample size for this study will be approximately 21 treated 
subjects.  
10.3 Populations for Analyses 
Full Analysis Set (FAS): All subjects who enroll in the study, provide informed consent , and 
receive study intervention. 
Per-Protocol (PP) Set: All subjects in the Full Analysis Set not identified as major protocol 
violations (defined to be protocol violations that may have a significant impact on subject 
outcomes, i.e., eligibility criteria not met). This population will be clearly defined prior to data 
analysis. 
The primary analysis will be based on the full analysis set. The per-protocol set will be 
supportive and will be used to assess the robustness of study results. Safety analysis will be 
based on the full analysis set. 

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This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential 
information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
10.4 Statistical Analyses 
10.4.1 General Approach 
Descriptive statistics will be used to summarize study outcomes. For categorical data, frequency 
counts and percentages will be provided. For continuous data, descriptive statistics, including 
sample size, mean, median, standard deviation, and range of values (i.e., minimum and 
maximum values) will be provided. 
All data collected in this study will be provided in subject data listings. Data collected in this 
study will be reported using summary tables and graphs as appropriate to the data. Descriptive 
summary statistics (n, mean, median, standard deviation, minimum and maximum) will be 
calculated for the continuous variables and/or frequencies and percentages will be produced for 
the categorical variables. 
10.4.2 Measures to Minimize Bias: Randomization and Blinding 
This study does not include a randomization or blinding component. When screening subjects 
for the study, the investigators or designee should offer participation to any/all patients who  
meet the inclusion and exclusion and who completed the prior T-GENVIH-002 study. 
10.4.3 Analysis of the Primary Endpoint(s) 
The primary endpoint for this study is descriptive statistics of clinically confirmed recurrence of 
the primary hernia to date, including not previously reported in T-GENVIH-002 study. 
10.4.4 Analysis of the Secondary Endpoint(s) 
Descriptive statistics will be provided for the following secondary endpoints: 
1. Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not 
previously reported in T-GENVIH-003 study. 
2. Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the 
primary hernia repair to date, including not previously reported in T-GENVIH-002. 
3. Incidence of  Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, 
abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), 
including not previously reported in T-GENVIH-002 study. 
4. Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not 
previously reported in GENVIH-002 study. 
5. Incidence of reoperation requirement of the primary hernia repair to date, including not 
previously reported in GENVIH-002 study. 

Integra LifeSciences Corporation  
T-GENVIH-003 study 
 
 
 
Confidential 
Protocol Version: V1.0 dated  02AUG2023  
 
Page 38 of 41 
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential 
information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
10.4.5 Safety Analyses 
All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and 
presented in by-subject listings. The number and percent of subjects experiencing any AE, any 
related AE, and discontinuations due to an AE will be tabulated. Treatment-emergent AEs will 
be tabulated (frequencies and percentages) by Preferred Term (PT) within System Organ Class 
(SOC). If a subject experiences more than one occurrence of the same AE, and these differ in 
severity and/or causality, the AE will be tabulated according to the greatest severity and nearest 
relationship to the device. Deaths and SAEs will be listed should they occur. 
10.4.6 Baseline Descriptive Statistics 
Nonapplicable. 
10.4.7 Planned Interim Analyses  
There is no planned Interim analysis.  
10.4.8 Sub-Group Analyses 
Subgroup analyses may be performed for surgical approach and type of the Gentrix Surgical 
Matrix used for cases of recurrence with reoperation post index procedure, if used. 
10.4.9 Tabulation of Individual participant Data 
All data collected in this study will be provided in subject data listings by study visit. 
10.4.10 Sensitivity Analyses 
All data will be analyzed as they were collected in the database. Missing data will not be 
imputed. 
11 Regulatory, Ethical, Compliance and Operational 
Considerations 
11.1 Informed Consent and Informed Consent Process 
For this study, an IRB approved consent and consent process were used. 
11.2 Protocol Amendment 
Investigator may not modify (amend) this clinical investigation plan without obtaining written 
concurrence of the Sponsor, involved Ethics Committee(s), and applicable regulatory authorities. 

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Protocol Version: V1.0 dated  02AUG2023  
 
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information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
11.3 Protocol Deviations  
A Deviation is an Instance of failure to follow, intentionally or unintentionally, the requirements of 
the CIP. The investigator is not allowed a planned deviation from the CIP without first receiving 
approval in writing from the Sponsor.  
Such deviations are documented on eCRFs and reported to the Sponsor as soon as possible. 
11.4 Publication Policy 
Integra LifeSciences Corporation may at any time publish the results of and information pertaining 
to the participating subject only to compliance with regulatory requirements pertaining to patient 
protected health information.  
After closure of the clinical investigation, the results will be summarized in a Clinical Investigation 
Report, which will be submitted to the investigator and appropriate regulatory authorities. This 
Clinical Investigation Report will include a summary of the results based on a statistical evaluation 
and clinical assessment.  
The conditions under which an investigator may publish results from this study in any form are 
defined in detail in the clinical trial agreement.  
The 
clinical 
investigation 
will 
be 
registered 
in 
a 
publicly 
accessible 
database 
(www.clinicaltrials.gov) prior to start of recruitment, contents will be updated throughout study 
conduct and results will be entered at study completion.  
 
 

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Protocol Version: V1.0 dated  02AUG2023  
 
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information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
12 References 
1Bosanquet DC, Ansell J, Abdelrahman T, et al. Systematic review and meta-regression of 
factors affecting midline incisional hernia rates: analysis of 14,618 patients. Plos One. 
2015;10:e0138745. 
1 Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, et al. Epidemiology and cost 
of ventral hernia repair: making the case for hernia research. Hernia 2012;16:179-83. 
2Luijendijk RW, HopWC, VanDen TolMP et al. A comparison of suture repair with mesh repair 
for incisional hernia. N. Engl. J. Med. 343(6), 392–398 (2000). 
3Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up 
of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann. Surg. 
240(4), 578–583 (2004). 
4Novitsky YW, Fayezizadeh M, Majumder A, Neupane R, Elliott HL, Orenstein SB (2016) 
Outcomes of Posterior Component Separation with Transversus Abdominis Muscle Release 
and Synthetic Mesh Sublay Reinforcement. Ann Surg 264(2):226–
232. https://doi.org/10.1097/SLA.0000000000001673. 
5Schneeberger S., Phillips S., Huang L.C., Pierce R.A., Etemad S.A., Poulose B.K. Cost-Utility 
Analysis of Biologic and Biosynthetic Mesh in Ventral Hernia Repair: When Are They Worth 
It? J. Am. Coll. Surg. 2019;228:66–71. doi: 10.1016/j.jamcollsurg.2018.10.009. 
6Skipworth JR, Vyas S, Uppal L, Floyd D, Shankar A. Improved outcomes in the management of 
high-risk incisional hernias utilizing biological mesh and soft-tissue reconstruction: a single 
center experience. World J Surg. 2014;38(5):1026–1034. 
7Smart NJ, Marshall M, Daniels IR (2012) Biological meshes: a review of their use in abdominal 
wall hernia repairs. Surgeon 10(3):159–171 
8Basta et al. Assessing complications and cost-utilization in ventral hernia repair utilizing 
biologic mesh in a bridged underlay technique. Am J Surg. 2015:209(4):695-702. 
 9 Augenstein V, Colavita P, Wormer B, Walters A, Bradley J, Lincourt A, et al. CeDAR: 
Carolinas equation for determining associated risks. J Am Coll Surg 2015;221:S65-6. 
10Huntington, C. R., Cox, T. C., Blair, L. J., Schell, S., Randolph, D., Prasad, T., Lincourt, A., 
Heniford, B. T., & Augenstein, V. A. (2016). Biologic mesh in ventral hernia repair: Outcomes, 
recurrence, and charge analysis. Surgery, 160(6), 1517–1527. 
https://doi.org/10.1016/j.surg.2016.07.008.  
 
11 Song C, Liu E, Tackett S, Shi L, Marcus D. Procedural volume, cost, and reimbursement of 
outpatient incisional hernia repair: implications for payers and providers. J Med Econ. 2017 
Jun;20(6):623-632. doi: 10.1080/13696998.2017.1294596. Epub 2017 Feb 28. PMID: 
28277031. 
 
 

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T-GENVIH-003 study 
 
 
 
Confidential 
Protocol Version: V1.0 dated  02AUG2023  
 
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information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation. 
13 APPENDIX I 
 
Table 3: List of 45Devices and SKU #  
Device Name 
Type: 
SKU # 
Size(s) 
Gentrix® Surgical Matrix (6-Layer) 
PSMX 
  PSMX0505  
5cm x 5cm 
  PSMX0710  
7cm x 10cm 
  PSMX1015  
10cm x 15cm 
Gentrix® Surgical Matrix Plus (8-Layer) 
MSPL 
  MSPL0507  
5cm x 7cm 
  MSPL0710  
7cm x 10cm 
  MSPL1010  
10cm x 10cm 
  MSPL1015  
10cm x 15cm 
Gentrix® Surgical Matrix Thick 
PSMT 
  PSMT1020  
10cm x 20cm 
  PSMT1620  
16cm x 20cm 
  PSMT2020  
20cm x 20cm 
  PSMT2025  
20cm x 25cm 
  PSMT2030  
20cm x 30cm 
  PSMT3030  
30cm x 30cm 
  PSMT3040  
30cm x 40cm 
 
 

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