A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
Phase: NA
Conditions: Hernia, Hernia, Abdominal, Hernia, Incisional
Sponsor: C. R. Bard

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CLINICAL STUDY PROTOCOL 
 
 
Title:                            
A Post-Market, Prospective, Multi-Center, Single-Arm 
Clinical Investigation of Phasix™ Mesh for VHWG 
Grade 3 Midline Hernia Repair 
 
Protocol Number:   
DVL-HE-016 
 
Study Type: 
Post-market, prospective, single arm, multi-center, 
open-label study (N=85) 
 
Date: 
12 Oct 2018  
 
Version: 
2.0 
 
Study Devices: 
Phasix™ Mesh 
 
Sponsor: 
Davol Inc. 
 
Subsidiary of C. R. Bard, Inc. 
 
100 Crossings Boulevard 
 
Warwick, RI 02886, USA 
 
Phone:  +1-800-556-6756 
 
Sponsor Contacts: 
Dawn Heimer 
Director, Clinical Affairs 
 
 
 
 
Davol Inc. 
 
100 Crossings Boulevard 
Warwick, RI 02886, USA 
Telephone: +1-401-825-8681 
Fax: +1-401-825-8759 
E-mail: dawn.heimer@crbard.com 
 
 
 
 
 
 
 
 
 
 

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Protocol Signature Page 
 
I have read this protocol and agree to adhere to the requirements.  I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision 
and the relevant Ethics Committee.  I will discuss this material with them and ensure they 
are fully informed regarding the conduct of the study according to ISO 14155:2011, the 
Declaration of Helsinki in its currently recognized version, and any national and local 
regulations. 
 
 
Agreed to by (Investigator):  
 
_______________________________________________ 
Printed Name – Investigator   
 
 
 
 
 
 
 
 
 
 
 
_______________________________________________ 
Signature – Investigator  
 
 
 
 
 
 
 
 
_______________________________________________ 
Date 
 
 
 
 
 
 

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Phasix Mesh™ Protocol Summary 
Title 
A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation 
of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair 
Study Device 
Phasix™ Mesh 
Study Design 
Post-market, prospective, single-arm, multicenter, open-label study (N=85).  
Region 
Europe 
Patient 
Population 
Ventral Hernia Working Group (VHWG) Grade 3 midline hernia patients.   
Grade 3 (potentially contaminated) includes the presence of a nearby stoma, 
bowel resection, violation of the gastrointestinal tract, or history of wound 
infection. 
Overview 
Approximately 85 subjects, at approximately 12 sites across Europe will be 
enrolled and treated to study the use of Phasix™ Mesh.  All treated subjects 
will be followed for 2 years post-implantation.   
Purpose 
The plan is to study the use of Phasix™ Mesh in VHWG Grade 3 midline 
hernia patients.   
Objective 
The objective of this study is to collect additional data on safety and 
performance of Phasix™ Mesh in subjects requiring VHWG Grade 3 midline 
hernia repair. 
Enrollment 
85 patients treated with PhasixTM Mesh at 12 clinical sites 
Estimated recruitment time: 15 months 
Estimated recruitment time + complete 2 years follow up visits: 39 months 
Subject Follow-
Up Schedule 
Follow-up visits will be conducted at drain removal (per standard of care, 
SOC), 1, 3, 6, 12, 18, and 24 months following surgery. 
Safety Review  
From the date of Phasix™ Mesh implant to each subject’s 3 month 
assessment visit, the following safety reassessment applies: 
Greater than 4 device-related SAEs or greater than 1 device-related 
recurrence.   
If the criteria for reassessment are met: 
1. Enrollment and implantations are suspended until the impact of the 
study parameters (e.g., surgical technique, hernia size/mesh size, 
protocol deviations (if any), AE time-course) on the results is 
assessed by the safety committee 
2. The follow-up for the subjects already treated continues 
Primary 
Endpoint 
Surgical Site Occurrence (SSO) rate up to (including) the 3-month (± 14 
days) Follow-Up Assessment:  
Occurrences at the surgical site will be assessed by physical examination at 
each study visit through 3 months (± 14 days). Surgical site occurrence will 
be defined as hematoma, seroma, surgical site infection, wound dehiscence, 
skin necrosis and fistula requiring intervention. 
Secondary 
Endpoints 
1. Surgical Site Occurrence (SSO) rate > 3-month follow-up assessment 
2. Hernia Recurrence Rate (via physical exam, if uncertain via 
ultrasonography, if uncertain, via CT/MRI). 
3. Surgical Site Infection rate 
4. Pain - Visual Analog Scale (VAS)  
5. Device-related adverse event incidence 
6. Rate of reoperation due to the index hernia repair 
7. Quality of life assessments (Carolinas Comfort Scale® and EQ-5D™) 
8. Surgical procedure time as measured from incision to closure (skin to 
skin) 

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9. Return to Work 
10. Length of stay in hospital (day of index surgery until day of discharge, 
LOS) 
Inclusion 
Criteria 
1. Subject must be 18 years of age or older. 
2. Subject must be diagnosed with incisional midline hernia. 
3. Subject has a VHWG Grade 3 hernia (as defined in the protocol). 
4. Size of hernia ≥ 10 cm2. 
5. Subject must be willing to undergo a planned retro-rectus hernia repair 
(onlay allowed as an exception when retro-rectus placement cannot be 
achieved; using absorbable suture) with or without Component Separation 
Technique (CST). 
6. The subject is legally competent, has been informed of the nature, the 
scope and the relevance of the study, voluntarily agrees to participation 
and the study’s provisions, and has duly signed the informed consent form 
(ICF). Subject agrees to comply with the protocol-mandated procedures 
and visits. 
Exclusion 
Criteria 
1. Subject with > 4 previous repairs of the hernia under observation. 
2. Body Mass Index (BMI) > 35 kg/m2. 
3. The subject is on, or suspected to be placed on, chemotherapy 
medications during any part of the study. 
4. The subject has peritonitis. 
5. Known human immunodeficiency virus (HIV) infection (if documented 
in the subject’s record). 
6. The subject has cirrhosis of the liver and/or ascites. 
7. Subject is American Society of Anesthesiology Class 4 or 5. 
8. Complete removal of existing mesh from a prior hernia repair (in the 
same affected area) is not possible. 
9. The hernia repair requires more than a single piece mesh (with adequate 
overlap beyond the margins of the defect on all sides).  
10. Subject has intact permanent mesh adjacent to the current hernia to be 
repaired. 
11. Subject’s hernia repair requires intraabdominal mesh placement. 
12. Surgical technique requires surgical bridge repair as the sole repair.  
13. Subject has any condition that, in the opinion of the Investigator, would 
preclude the use of the study device, or preclude the subject from 
completing the follow-up requirements. 
14. Subject is pregnant or has plans to become pregnant during the study 
period or is currently breastfeeding. 
15. Subject has an alcohol/substance abuse problem or has had a relapse 
within 12 months of the screening visit. 
16. Subject was involved in another interventional clinical study in the last 30 
days prior to ICF signature. 
17. Subject is part of the site personnel directly involved with this study. 
18. Subject has a life expectancy of less than 2 years at the time of 
enrollment. 
19. Subject has a known sensitivity to Phasix™ Mesh or component 
materials (patients with known allergies to tetracycline hydrochloride or 
kanamycin sulfate should be avoided). 
Primary 
Analysis Subset 
Modified intention-to-treat (mITT) population which is defined as all 
subjects in whom Phasix Mesh has been implanted.  

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Coordinating 
Investigator 
Professor Hans Jeekel 
Erasmus University Medical Centre Rotterdam 
Department of Neuroscience and Anatomy 
s-Gravendijkwal 230, 3015 CE  
Rotterdam, The Netherlands 
 
Telephone: +31-654736337 
E-mail: j.jeekel@erasmusmc.nl 
Sponsor/ 
Contact 
Dawn Heimer 
Director, Clinical Affairs 
 
 
 
 
Davol, Inc. 
 
100 Crossings Boulevard 
Warwick, RI 02886, USA 
Telephone: +1-401-825-8681 
Fax: +1-401-825-8759 
E-mail: dawn.heimer@crbard.com 
EU CRO 
Monika Bamberger 
Project Manager 
FGK Clinical Research GmbH,  
Heimeranstr. 35, 80339 Munich, Germany 
Phone:     +49 - 89-893 119-132 
Fax:         +49 - 89-893 119-20 
Mobile:   +49 - 162 1728 064 
E-mail:    monika.bamberger@fgk-cro.com 
Electronic Data 
Capture (EDC) 
Trium Analysis Online GmbH 
Munich, Germany 
EU Authorized 
Representative 
BARD Limited 
Tilgate Forest Business Park 
Brighton Road Crawley 
West Sussex RH11 9BP, UK 
Tel.: +44 - 1293 527888  

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Protocol Abbreviations/Acronyms 
 
Abbreviation/Acronym 
Definition  
ADE 
Adverse Device Effect 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BMI 
Body Mass Index 
CAD 
Coronary Artery Disease 
CBGB 
Coronary artery bypass graft with both chest and donor site incisions  
CCS 
Carolina Comfort Scale 
CDC 
US Centers for Disease Control and Prevention 
CE 
Conformité Européenne 
CIP 
Clinical Investigational Plan 
cm 
Centimeter 
COPD 
Chronic Obstructive Pulmonary Disease 
CRO 
Clinical Research Organization 
CST 
Component Separation Technique 
CT 
Computed Tomography Scan 
CV 
Curriculum vitae 
DIP 
Deep Incisional Primary 
DIS 
Deep Incisional Secondary 
DM 
Diabetes Mellitus 
DMP 
Data Management Plan 
e.g. 
For Example 
early term. /ET 
Early Termination Visit 
eCRF 
Electronic Case Report Form 
EEA 
European Economic Area 
EEC 
European Economic Community 
EQ-5D 
EuroQol 5 Dimensions 
etc. 
Et Cetera. 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
gastrointestinal 
HIV 
Human Immunodeficiency Virus 
Hrs 
Hours 
i.e. 
That Is 
ICF 
Informed Consent Form 
IFU 
Instructions For Use 
Inc. 
Incorporated 
ISO 
International Organization for Standardization 
ITT 
Intention-to-treat 
LOS 
Length of stay 

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LTF 
Lost to Follow-Up 
mITT 
Modified Intention-to-treat 
mm 
Millimeter 
MRI 
Magnetic Resonance Imaging 
N 
Sample Size 
NL 
Netherlands 
OTC 
Over the Counter 
P4HB 
poly-4-hydroxybutyrate 
PE 
Physical Examination 
PP 
Per Protocol 
QoL 
Quality of Life 
RCT 
Randomized Controlled Trial 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SIP 
Superficial Incisional Secondary 
SIS 
Superficial Incisional Primary 
SOC 
Standard of Care 
SSI 
Surgical Site Infection 
SSO 
Surgical Site Occurrence 
TM 
Trademark 
unsched. 
unscheduled 
US 
United States 
VAC 
Vacuum Assisted Closure system 
VAS 
Visual Analogue Scale 
VHWG 
Ventral Hernia Working Group 
 

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TABLE OF CONTENTS 
 
1. 
INTRODUCTION..................................................................................................... 11 
1.1. 
Background ........................................................................................................... 11 
1.2. 
Rationale ................................................................................................................ 12 
1.3. 
Device Descriptions ............................................................................................... 13 
2. 
STUDY OBJECTIVES ............................................................................................. 13 
3. 
STUDY ENDPOINTS ............................................................................................... 13 
3.1. 
Primary Endpoint ................................................................................................. 13 
3.2. 
Secondary Endpoints ............................................................................................ 14 
4. 
STUDY DESIGN ....................................................................................................... 14 
5. 
STUDY POPULATION ........................................................................................... 14 
5.1. 
Number of Subjects ............................................................................................... 14 
5.2. 
Eligibility Criteria ................................................................................................. 15 
5.2.1. Inclusion Criteria .................................................................................................... 15 
5.2.2. Exclusion Criteria ................................................................................................... 15 
5.2.3. Definition of VHWG Grade 3 Hernia for this protocol .......................................... 16 
6. 
STUDY PROCEDURES .......................................................................................... 16 
6.1. 
Subject Screening and Baseline Evaluation ....................................................... 16 
6.1.1. Informed Consent.................................................................................................... 17 
6.1.2. Enrollment............................................................................................................... 17 
6.1.3. Eligibility ................................................................................................................ 17 
6.1.4. Assignment of Subject Screening Number ............................................................. 17 
6.1.5. Demographics and Medical History ....................................................................... 18 
6.1.6. Physical Examination.............................................................................................. 18 
6.1.7. Concomitant Pain Medication Usage...................................................................... 18 
6.1.8. Patient Reported Outcome Assessments ................................................................. 18 
6.2. 
Surgical Procedure ................................................................................................ 18 
6.3. 
Subject Follow-up ................................................................................................. 19 
6.3.1. Subjects not Implanted and Surgical Repair Failures ............................................. 19 
6.3.2. Subjects Successfully Implanted ............................................................................. 19 
6.3.3. Subjects Completed the Study ................................................................................ 19 
6.3.4. Assessments ............................................................................................................ 19 
6.3.5. Unscheduled Visits ................................................................................................. 20 
6.4. 
TABLE OF STUDY EVENTS ............................................................................. 21 

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6.5. 
Withdrawal and/or Early Termination .............................................................. 22 
7. 
STATISTICAL METHODS .................................................................................... 22 
7.1. 
Sample Size Considerations ................................................................................. 22 
7.2. 
Data Analysis ......................................................................................................... 23 
8. 
ADVERSE EVENTS ................................................................................................ 24 
8.1. 
Definition of Adverse Event ................................................................................. 24 
8.2. 
Definition of Adverse Device Effect ..................................................................... 24 
8.3. 
Definition of Serious Adverse Event ................................................................... 25 
8.4. 
Serious Adverse Device Effect ............................................................................. 25 
8.5. 
Relationship of Adverse Event to Device/Procedure ......................................... 25 
8.6. 
Severity of Adverse Events ................................................................................... 26 
8.7. 
Reporting of Adverse Events ............................................................................... 26 
9. 
SAFETY COMMITTEE .......................................................................................... 27 
10. 
DEVICE DEFICIENCY REPORTING AND MANAGEMENT ........................ 27 
11. 
ELECTRONIC CASE REPORT FORMS ............................................................. 27 
12. 
RISK/BENEFIT ANALYSIS ................................................................................... 27 
13. 
DATA COLLECTION AND MONITORING ....................................................... 28 
13.1. Data collection ....................................................................................................... 28 
13.1.1. Electronic Case Report Form (eCRF) ..................................................................... 28 
13.1.2. Monitoring .............................................................................................................. 28 
13.1.3. Source Documentation ............................................................................................ 28 
13.1.4. Data Management ................................................................................................... 29 
13.1.5. Record Retention .................................................................................................... 29 
14. 
ADMINISTRATIVE REQUIREMENTS ............................................................... 29 
14.1. Publication Policy .................................................................................................. 29 
14.2. Investigator Selection ............................................................................................ 29 
14.3. Regulatory and Ethical Considerations .............................................................. 30 
14.3.1. Ethics Committee Approval .................................................................................... 30 
14.3.2. Authorization from / notification to competent authority ....................................... 30 
14.3.3. Informed Consent.................................................................................................... 30 
14.3.4. Confidentiality ........................................................................................................ 31 
14.4. Protocol Adherence, Deviations and Amendments............................................ 31 
14.5. Device Accountability ........................................................................................... 31 
14.6. Subject Compensation .......................................................................................... 31 
15. 
TERMINATION OF STUDY .................................................................................. 31 

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16. 
STATEMENT OF COMPLIANCE ........................................................................ 32 
17. 
REFERENCES .......................................................................................................... 33 
18. 
APPENDIX ................................................................................................................ 35 
18.1. Appendix A: Surgical Site Infection Criteria17 .................................................. 35 
 
 

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1. 
INTRODUCTION 
1.1. Background 
 
The incidence of incisional hernias is 10 to 20 %, making it one of the most common 
surgical complications after laparotomy. 1, 3 
        
Ventral and incisional hernias are treated with surgery to relieve symptoms (pain and 
discomfort), to prevent complications (strangulation, respiratory dysfunction, or skin 
problems), or to resolve acute complications (incarceration, perforation and 
strangulation).  
 
There are several options for repair, including primary repair, synthetic or biologic 
material placement, repair with relaxing incisions, component separation and use of 
musculofascial flaps, utilizing both open and laparoscopic approaches. 5, 6, 7 However, 
there is no clear-cut consensus regarding the optimal hernia repair technique, particularly 
in complex hernia repair cases where patient co-morbidities exist and a high risk of 
infection is present.    
 
Primary suture repair has been associated with a high risk of hernia recurrence, with 
reports ranging from 10% to 55%, and has been nearly abandoned for the repair of 
hernias which are greater than five centimeters (cm) in size. 3, 4, 5  As a result, most ventral 
hernia repair procedures involve the use of a mesh.    
 
Synthetic mesh repair procedures, either open or laparoscopic, have been reported to lead 
to fewer recurrences compared to primary repairs.2, 3, 4, 6  Improved outcomes are believed 
to be related to reduced tension on the fascial edges and sutures when mesh is used in 
hernia repair procedures.  However, complex cases and large abdominal wall defects 
continue to pose a challenge to surgeons.  Factors such as patient co-morbidities, defect 
size, location, tissue viability and degree of contamination are included in a surgeon’s 
assessment and decision-making process.10 These large abdominal wall defects have been 
associated with recurrence rates of up to 46%.10 
 
Despite reducing hernia recurrence rates, the use of synthetic mesh has been associated 
with complications such as infection, pain, adhesions, fistulae, and foreign body reactions 
including increased inflammation and/or connective tissue deposition.11 
 
Non-resorbable meshes can lead to complications related to the body’s reaction to the 
persistent foreign mesh material resulting in foreign body sensations including discomfort 
and chronic pain, which is described by the International Association for the Study of 
Pain as pain lasting for 3 months or greater following hernia repair.12, 13 
 
Ideally, a resorbable mesh should provide adequate structural support throughout the 
healing process and at the same time it should be fully resorbed when the wound has 
completely healed, thereby potentially reducing the chances for complications associated 
with the persistence of non-resorbable mesh material.  However, the development of 
resorbable mesh products has faced challenges related to the rate of absorption with 
complications arising when the mesh product is resorbed too quickly.  Rapid resorption 
does not support sufficient healing if structural reinforcement is diminished during the 
tissue repair period.  A resorbable mesh should retain its functional strength for a 

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sufficient period of time to allow native cellular ingrowth tissue remodeling, maturation 
of collagen, and gradual shift of mechanical load. 
 
Phasix™ Mesh is a commercially available medical device. It is a resorbable mesh 
prepared from poly-4-hydroxybutrate (P4HB) which has been studied for use as a 
biomaterial for a number of applications in medical devices and tissue engineering due to 
favorable mechanical properties, biocompatibility and desirable degradation times.14, 15, 16  
Using standard measures of mechanical strength (suture pull-out, tear and ball burst 
strength) Phasix™ Mesh is comparable in performance to traditional polypropylene mesh. 
Per the Instructions for Use (IFU), pre-clinical implantation studies indicate that Phasix™ 
Mesh retains approximately 70% of its strength at 12 weeks.  Absorption of the mesh 
material will be essentially complete in 12-18 months.    Given the long-term strength 
retention observed in preclinical studies, it is anticipated that Phasix™ Mesh may result 
in low recurrence and complication rates with minimal pain and discomfort when used for 
hernia repair.  
 
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia 
Repair of 121 subjects is ongoing in the United States.  All subjects will be at 12 months 
follow-up in January 2016.  Inclusion criteria include: 1. Primary ventral, incisional or 
recurrent (not to exceed 3) incisional hernias undergoing retro-rectus or onlay repair, 2. 
Presence of 1 or more comorbid conditions (obesity, smoking, diabetes mellitus, chronic 
steroid use, COPD, coronary artery disease, immunosuppression, hypoalbuminemia, renal 
insufficiency, age>75), 3. Hernia size > 10 cm2 and < 350 cm2, 4. CDC Class 1 wound.  
Demographic information, operative details, quality of life surveys, visual analog pain 
scores and postoperative outcomes are measured at 1, 3, 6, 12, 18, 24 and 36 months. As 
per June 2015 there have been two recurrences and no unexpected adverse events. The 
adverse events have not occurred with a greater frequency or severity than expected. 
 
A Prospective, Multi-Center All Comers Study of a Novel Resorbable Mesh (Phasix™ 
Mesh) for Ventral or Incisional Hernia Repair is an ongoing single-arm interventional 
study of 25 subjects to collect additional data on safety, performance, and effectiveness of 
Phasix™ Mesh in subjects requiring primary ventral or incisional hernia repair out to 24 
months follow-up.  
 
This post-commercialization clinical study is being conducted to evaluate the use of 
Phasix™ Mesh in incisional midline hernia repair in Ventral Hernia Working Group 
(VHWG) Grade 3 patients.  All treated subjects will be followed for 24 months post-
implantation. 
 
1.2. Rationale 
 
This study is intended to evaluate the use of Phasix™ Mesh in VHWG Grade 3 patients 
in terms of performance and safety. Until now the use of Phasix™ Mesh was studied 
primarily in patients up to VHWG Grade 2, i.e. broad data on its use in a population of 
higher risk will be gained from this study. From a general perspective, the current 
literature still is rather void of evidence-based guidelines regarding optimal choice of 
mesh. Biologic meshes are mostly used in these cases, since mesh infection is anticipated 
postoperatively.  

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Hence, based on the data gained from this clinical study additional evidence may be 
provided with a view to optimal selection of hernia repair material. Another aspect of this 
clinical study deals with the investigation of cost-effectiveness concerning the use of 
Phasix™ Mesh in VHWG Grade 3 patients. The most wide-spread treatment option in 
patients with potentially infected surgeries currently consists in the use of cost-intensive 
biologic repair materials. 
 
The combination of the features of the Phasix™ Mesh as proven in previous clinical and 
non-clinical investigations (resorbable with constant repair strength, monofilament 
structure) and based on evidence from this clinical study, Phasix™ Mesh may become a 
treatment alternative in VHWG Grade 3 patients.  
 
1.3. Device Descriptions 
 
The Phasix™ Mesh (manufacturer: Davol Inc.) is a resorbable mesh prepared from poly-
4-hydroxybutyrate (P4HB).  P4HB is produced from a naturally occurring monomer and 
is processed into monofilament fibers and knitted into a surgical mesh.  Phasix™ Mesh 
degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process.  It 
was developed to minimize the variability of resorption rate (loss of mass) and strength 
and provide support throughout the expected period of healing. 
 
Pre-clinical implantation studies indicate that Phasix™ Mesh retains approximately 70% 
of its strength at 12 weeks.  Absorption of the mesh material will be essentially complete 
in 12-18 months. 
 
Phasix™ Mesh has been commercially available in the US since 2012 and received CE 
Marking in 2015. As per its EEA approved intended use Phasix™ Mesh is indicated to 
reinforce soft tissue where weakness exists in patients undergoing abdominal plastic and 
reconstructive surgery, or for use in procedures involving soft tissue repair of ventral or 
inguinal hernias, or other abdominal fascial defects that require the addition of a 
reinforcing or bridging material to obtain the desired surgical result.  Since Phasix™ 
Mesh is fully resorbable, it should not be used in repairs where permanent wound or 
organ support from the mesh is required.  A full description of Phasix™ Mesh is included 
in the product’s IFU. 
 
2. 
STUDY OBJECTIVES  
 
The objective of this study is to collect additional data on safety and performance of 
Phasix™ Mesh in subjects requiring VHWG Grade 3 midline hernia repair.  The study 
end points are described below. 
 
3. 
STUDY ENDPOINTS 
3.1. Primary Endpoint 
 
Surgical Site Occurrence (SSO) rate up to and including, the 3-month (± 14 days) follow-
up assessment. 
 

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Occurrences at the surgical site will be assessed by physical examination at each study 
visit through 3 months (± 14 days). Surgical site occurrence will be defined as hematoma, 
seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring 
intervention. 
 
3.2. Secondary Endpoints 
 
1. Surgical Site Occurrence (SSO) rate > 3-month follow-up assessment 
2. Hernia Recurrence Rate (via physical exam, if uncertain via ultrasonography, if 
uncertain, via CT/MRI)  
3. Surgical Site Infection rate (see 18.1) 
4. Pain - Visual Analog Scale (VAS)  
5. Device related adverse event incidence 
6. Rate of reoperation due to the index hernia repair 
7. Quality of life assessments (Carolinas Comfort Scale® and EQ-5D™) 
8. Surgical procedure time as measured from incision to closure (skin to skin) 
9. Return to work 
10. Length of hospital stay (day of index surgery until day of discharge, LOS) 
 
4. 
STUDY DESIGN 
 
Approximately 85 subjects, at approximately 12 sites will be enrolled and treated to study 
the use of Phasix™ Mesh.  All treated subjects will be followed for 2 years post-
implantation. Follow-up visits will be conducted at Drain Removal per standard of care 
(SOC), 1, 3, 6, 12, 18 and 24 months following implantation. See Section 6 for a detailed 
schedule of study visits and procedures.   
 
From the date of Phasix™ Mesh implant to each subject’s 3 month assessment visit, the 
following safety reassessment applies: 
 
Greater than 4 device-related SAEs or greater than 1 device-related recurrence. 
 
If the criteria for reassessment are met: 
 
1. Enrollment and implantations are suspended until the impact of the study 
parameters (e.g., surgical technique, hernia size/mesh size, protocol deviations (if 
any), AE time-course) on the results is assessed by the safety committee. 
2. The follow-up for the subjects already treated continues. 
 
5. 
STUDY POPULATION 
5.1. Number of Subjects 
 
This study is projected to treat 85 subjects with PhasixTM Mesh at approximately 12 sites. 
For the calculation of the sample size see section 7.1.  
 
 
 

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5.2. Eligibility Criteria 
5.2.1. 
Inclusion Criteria 
 
The subject must meet all of the criteria listed below to be enrolled in the study: 
1. Subject must be 18 years of age or older. 
2. Subject must be diagnosed with incisional midline hernia. 
3. Subject has a VHWG Grade 3 hernia (as defined in 5.2.3). 
4. Size of hernia ≥ 10 cm2. 
5. Subject must be willing to undergo a planned retro-rectus hernia repair (onlay 
allowed as an exception when retro-rectus placement cannot be achieved; using 
absorbable suture) with or without Component Separation Technique (CST). 
6. The subject is legally competent, has been informed of the nature, the scope and 
the relevance of the study, voluntarily agrees to participation and the study’s 
provisions, and has duly signed the informed consent form (ICF). Subject agrees 
to comply with the protocol-mandated procedures and visits. 
 
5.2.2. 
Exclusion Criteria 
 
The subject must be excluded from study enrollment if any of the following criteria are 
met: 
1. Subject with > 4 previous repairs of the hernia under observation. 
2. Body Mass Index (BMI) > 35 kg/m2. 
3. The subject is on, or suspected to be placed on, chemotherapy medications during 
any part of the study. 
4. The subject has peritonitis. 
5. Known human immunodeficiency virus (HIV) infection (if documented in the 
subject’s record). 
6. The subject has cirrhosis of the liver and/or ascites. 
7. Subject is American Society of Anesthesiology Class 4 or 5. 
8. Complete removal of existing mesh from a prior hernia repair (in the same 
affected area) is not possible. 
9. The hernia repair requires more than a single piece mesh (with adequate overlap 
beyond the margins of the defect on all sides).  
10. Subject has intact permanent mesh adjacent to the current hernia to be repaired. 
11. Subject’s hernia repair requires intraabdominal mesh placement. 
12. Surgical technique requires surgical bridge repair as the sole repair.  
13. Subject has any condition that, in the opinion of the Investigator, would preclude 
the use of the study device, or preclude the subject from completing the follow-up 
requirements. 
14. Subject is pregnant or has plans to become pregnant during the study period or is 
currently breastfeeding. 
15. Subject has an alcohol/substance abuse problem or has had a relapse within 12 
months of the screening visit. 
16. Subject was involved in another interventional clinical study in the last 30 days 
prior to ICF signature. 
17. Subject is part of the site personnel directly involved with this study. 
18. Subject has a life expectancy of less than 2 years at the time of enrollment. 

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19. Subject has a known sensitivity to Phasix™ Mesh or component materials 
(patients with known allergies to tetracycline hydrochloride or kanamycin sulfate 
should be avoided). 
 
5.2.3. 
Definition of VHWG Grade 3 Hernia for this protocol 
 
The table below provides some examples of surgical cases that would be considered 
Grade 3 or Grade 4. This is not a complete or definitive list. 
Grade 3 Included 
Excluded (considered Grade 4) 
Previous wound infection after previous laparotomy 
Active infection 
Small bowel resection with anastomosis 
Infected Mesh 
Take down of ileostomy (or colostomy) with ileocolonic 
anastamosis 
Uncontrolled spillage into surgical site 
Creation of a stoma 
Active fistula 
Violation of the GI tract 
Surgical site contains pus 
Stoma present 
Abscess 
Cholecystectomy during hernia repair 
 
 
The table below provides examples of commonly planned concomitant procedures and 
how they would affect the hernia grading assessment. 
Other Concomitant Procedures 
Grade Determination 
Repair of small bowel serosal tears 
Grade 2 
Hysterectomy 
Grade 2 
Bilaterial salpingo-oophrectomy 
Grade 2 
Repair of epigastric hernia 
Grade 2 
Bladder repair 
Grade 3 
Superficial cautery injury to loop of bowel with no deserosalization 
Grade 2 (if no enterotomy) 
Jejunostomy 
Grade  3 
Gastrectomy 
Grade  3 
 
 
6. 
STUDY PROCEDURES 
6.1. Subject Screening and Baseline Evaluation 
 
Subjects with a diagnosis of incisional midline hernia requiring surgical repair to close 
the defect who are presenting at the study site will be considered potential subjects for 
inclusion in this clinical study and should be pre-screened for study eligibility. If 
inclusion criteria are potentially met and no exclusion criteria are anticipated to be present 
at the time of such pre-screening (except for the informed consent which still needs to be 

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obtained), the Investigator will discuss the study and invite the patient to participate in 
accordance with the processes as described in section 14.3.3 in order to seek their 
informed consent to be given. Within 60 days from having obtained the subjects’ 
informed consent, they will be screened for potential eligibility against the study protocol 
inclusion and exclusion criteria, utilizing ordinary standard of care procedures (e.g. 
physical examination, blood work, medical evaluation).   
 
Written informed consent must be obtained prior to performance of any protocol specific 
procedures.  
 
The following screening/baseline procedures will be conducted and documented. 
 
6.1.1. 
Informed Consent  
 
The investigator will explain the study to the subject, answer all of the subject’s 
questions, and obtain written informed consent in a language in which the subject is 
fluent before the collection of any study data or performance of any study procedures.  
 
The subject must have signed and dated the informed consent form prior to the collection 
of study data or performance of any study procedures. Documentation of the Informed 
Consent process must be present in the medical record and/or source documents. The 
original, signed informed consent will be retained with the subjects’ records and a copy 
provided to the subject.  
 
6.1.2. 
Enrollment 
 
Subjects who sign an informed consent will be considered enrolled in this study.  Subjects 
who provide consent for participation but do not meet all of the study eligibility criteria 
and do not receive the study device will be considered screen failures. 
 
6.1.3. 
Eligibility 
 
The subject’s eligibility for study enrollment will be reviewed and documented in the 
appropriate eCRF.  At the time of screening, a related progress note must be entered in 
the source documentation to indicate that all eligibility criteria were reviewed and 
screening results noted. Final eligibility will be determined intraoperatively. 
 
Subjects who fail to meet eligibility criteria should be considered screen failures and 
treated according to the Investigator’s standard of care. Data are to be collected for screen 
failure subjects from the time the ICF is signed until the subject is deemed a failure. At a 
minimum, subject demographics and the reason for failure must be collected; adverse 
events (AEs) will also be collected and followed through satisfactory resolution or 
stabilization.  
6.1.4. 
Assignment of Subject Screening Number 
 
Subject numbers will be assigned in sequential order, consisting of eight digits where the 
first two letters designate the country, the next three digits designate the study site and the 
last three digits designate the subject number (i.e., subject number NL 101 001 will be the 

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first subject at site 101 in the Netherlands; NL 101 002 will be the second subject at site 
101, etc.). 
 
6.1.5. 
Demographics and Medical History 
 
The subject’s medical history and demographic information will be documented in 
medical records and on the appropriate eCRF.  Demographic information will include 
sex, age, race and ethnicity (as appropriate in the respective countries).   
 
6.1.6. 
Physical Examination 
 
A standard physical examination, appropriate to subjects about to undergo abdominal 
surgery, will be performed by the physician.  Height and weight measurements will be 
recorded to allow for the calculation of BMI. 
 
Length and width of the hernia should be described, as well as surgical site assessment 
(signs of infection, status and location of potential previous mesh, signs of necrosis). 
 
6.1.7. 
Concomitant Pain Medication Usage  
 
All current prescription and over the counter (OTC) pain medication must be recorded in 
the source documentation and in the eCRF on the pain medication log page at baseline. In 
addition, all pain medication related to AEs must be recorded during the course of the 
study.  
 
6.1.8. 
Patient Reported Outcome Assessments 
 
Subjects will complete the Pain VAS, Carolinas Comfort Scale® and EQ-5D™ to measure 
pain, discomfort and quality of life.   
 
6.2. Surgical Procedure 
 
All subjects will undergo an open ventral repair of hernias. The size of the hernia is an 
intraoperative inclusion criterion and must be greater than 10 cm2.  All other 
intraoperative exclusion criteria should be verified (e.g., absence of an active infection; 
presence of peritonitis; requirement of a hernia bridge as the sole repair procedure). 
Defect closure must be confirmed.  
 
The surgical technique will require retro-rectus (onlay is allowed as an exception when 
retro-rectus placement cannot be achieved), using resorbable suture, with or without 
Component Separation Technique (CST). Subjects will be administered antibiotics 
according to hospital protocol. Subjects will be prepared to undergo hernia repair with 
Phasix™ Mesh following the instructions supplied by the manufacturer. 
 
Phasix™ Mesh will be placed in the retro-rectus space with resorbable sutures. The 
peritoneum should remain posterior to the mesh upon completion of mesh placement. 
Mesh may be cut to shape or size desired for each specific application. To prevent 
recurrence when repairing hernias, a mesh larger than the defect is required to ensure 

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adequate coverage. The mesh is to be positioned so its edges extend beyond the margins 
of the defect by at least 5 cm. It is recommended that fixation be placed at approximately 
5 to 6 cm intervals (6 to 12 resorbable sutures) around the periphery of the mesh. The 
edges are then fixated to assure proper closure under correct tension.  
 
The procedure may include CST to obtain site closure. All incisions will be closed with 
staples and/or sutures and wounds will be dressed with sterile occlusive dressings. 
 
The following information will be collected in the eCRF: 
• Intra-operative evaluation of wound and abdomen 
• Intra operative assessment and description of hernia 
• Intraoperative assessment of complications e.g. enterotomy 
• Surgical procedure 
• Mesh details 
• Fixation details 
• Pre- and post-operative wound assessment  
o Signs of infection 
o Status and location of potential previous mesh 
o Signs of necrosis 
• Wound closure 
• Adverse Events 
• Device failure/ malfunction/ defects 
 
6.3. Subject Follow-up 
6.3.1. 
Subjects not Implanted and Surgical Repair Failures 
 
Subjects who are screened but do not meet the inclusion criteria or who fulfill one or 
more of the exclusion criteria shall be considered a screen failure and will be treated per 
hospital standard of care.  
 
Reason for failure of the surgical repair procedure, as well as all information outlined in 
the Day of Surgery eCRFs must be recorded in the source documentation. 
 
6.3.2. 
Subjects Successfully Implanted 
 
Subjects successfully implanted with Phasix™ Mesh will be followed as per the protocol 
defined follow-up procedures (see Table of Study Events).  
 
6.3.3. 
Subjects Completed the Study 
 
Subjects who completed the study (regular or premature termination) will be subject to 
the common medical standard for further treatment of their condition. 
 
6.3.4. 
Assessments 
 
Subjects should report to the study site for visits at the following times post-implantation: 
 

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• Drain removal: 
per site’s SOC 
• 1 month:    
 
Day 30 + 7 days 
• 3 months:    
 
Day 90 + 14 days 
• 6 months:    
 
Day 180 + 30 days 
• 12 months:  
 
Day 365 + 60 days 
• 18 months:  
 
Day 545 + 60 days 
• 24 months:  
 
Day 730 + 60 days 
 
At each study visit (also unscheduled/early termination visits), the following procedures 
will be completed and these data recorded in source documentation and on the eCRF:  
 
• Physical examination to check for hernia recurrence and surgical complications. 
Note: If the subject undergoes imaging for any reason and a recurrent hernia is 
identified, it must be recorded. 
• Surgical Pain Scale (VAS, about the last 24h)  
• Carolinas Comfort Scale® (except at Drain Removal visit) 
• EQ-5D™ (except at Drain Removal visit) 
• Assessment of AEs/complications 
o Pain related medication should be documented in the pain medication log 
page 
o Concomitant medication at the time of SAE and medication to treat the 
SAE will be documented on the SAE page 
• Device failure/ malfunctions/ defects 
 
In addition the following will be documented and recorded: 
• At month 12 and month 24 the current hernia associated pain medication usage 
 
6.3.5. 
Unscheduled Visits 
 
The investigator can choose to see the subject more frequently if needed or required; 
however, these visits will not be recorded as study visits unless they are directly related to 
study procedures (Adverse Events, etc.). 
 

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6.4. TABLE OF STUDY EVENTS  
 
Study 
Procedure 
Screening 
and 
Baseline 
Index 
Surgery 
 
Drain 
Removal4 
1 
Month 
Visit 
3 
Month 
Visit 
6   
Month 
Visit 
12 
Month 
Visit 
18 
Month 
Visit 
24 
Month 
Visit 
Unsched 
Visit / 
Early 
Term 
Visit Window 
(days) 
Within 60 
days of 
ICF signed 
0 
Per SOC 
30 ± 7 
90 + 14 
180 + 30 365 + 60 545 + 60 730 + 60 
-- 
Describe study 
to potential 
subject 
X 
 
 
 
 
 
 
 
 
 
Obtain informed 
consent 
X 
 
 
 
 
 
 
 
 
 
Collect 
demographics 
and medical 
history 
X 
 
 
 
 
 
 
 
 
 
Verify eligibility 
criteria 
X 
X1 
 
 
 
 
 
 
 
 
Physical 
examination 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Placement of 
Device 
 
X 
 
 
 
 
 
 
 
 
Pain Scale 
(VAS) 
X 
 
X2 
X 
X 
X 
X 
X 
X 
X 
Carolinas 
Comfort Scale® 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
EQ-5D™ 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Collect adverse 
events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect pain 
medications3 
X 
 
 
 
 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Schedule 
follow-up visit 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
1 Intraoperative verification of inclusion/ exclusion criteria 
2 Assessment BEFORE Drain Removal 
3 AE related pain medication should be documented on the pain medication log page 
4 In the case no drains were placed, the assessments will be done at day of discharge. In case several drains are 
placed and pulled at different time points, assessments on any of the days of drain removal is allowed.

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6.5. Withdrawal and/or Early Termination 
 
Following treatment, every subject should remain in the study until completion of the 
required follow-up period; however a subject’s participation may be discontinued. Should 
this occur, the reason for discontinuation must be captured in the source documentation. 
Potential reasons for discontinuation may include, but are not limited to the following: 
• Subject Withdrawal: Subject participation in a clinical study is voluntary, and the 
subject may discontinue participation (refuse all subsequent testing/follow-up) at 
any time without penalty or loss of benefits. Subjects who withdraw will not be 
replaced. 
• Investigator Termination: The Investigator may terminate the subject’s 
participation without regard to the subject’s consent if the Investigator believes it 
is medically necessary. Subjects terminated by the Investigator will not be 
replaced. 
• Lost-to-Follow-up: The subject does not complete a scheduled follow-up but has 
not “officially” withdrawn from the study. (This does not apply to missed visits, 
where the subject misses one or more of the follow-up contact time points, but 
completes a subsequent one).  In order to consider a subject lost-to-follow-up, site 
personnel should make all reasonable efforts to locate and communicate with the 
subject. A minimum of 3 attempts to contact the subject should be recorded in 
source documentation, including date and name of site personnel trying to make 
contact. Subjects who are lost to follow up will not be replaced. 
• Other 
 
A subject is considered an Early Termination (ET), if discontinuation occurs after study 
treatment and before 24 months follow-up.  The site should attempt to bring the subject 
back to complete all ET visit study procedures (see Table of Study Events) prior to 
ultimately declaring the subject’s discontinuation.  In particular, in case a subject is 
willing to withdraw consent, the investigator should seek without exerting any pressure to 
the patient the subject’s willingness to have an ET visit conducted prior to the formal 
declaration of withdrawal of consent. 
 
Once a subject discontinues from the study, the Investigator must complete the End of 
Study page in the eCRF and the reason for subject discontinuation should be documented 
whenever possible. 
 
7. 
STATISTICAL METHODS 
 
This section describes the planned statistical analyses for this study. A detailed Statistical 
Analysis Plan (SAP) will be completed and placed on file prior to database lock. The SAP 
will contain a comprehensive explanation of the methodology used in the statistical 
analyses described below.  
 
7.1. Sample Size Considerations 
 
This is a feasibility study aiming to collect additional data on safety and performance of 
Phasix™ Mesh in subjects requiring VHWG Grade 3 midline hernia repair. There is no 
formal hypothesis test in this study and the result of the study is not for claiming purpose. 

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The study plans to include 85 subjects for follow-up, meaning 85 subjects having been 
treated with Phasix™ Mesh.  Assuming an attrition rate of about 10%, 75 subjects will be 
evaluable to assess the primary endpoint of Surgical Site Occurrence (SSO) at 3 months. 
The expected rate of SSO at 3 months is 37% based on historically data. With 75 subjects, 
the accuracy of the estimated rate of SSO will be +/- 11% (i.e., half of the width of the 
95% confidence interval of the estimated rate of SSO is 11%). 
 
7.2. Data Analysis 
 
During the study a continuous safety review will be done. In the case the criteria for 
safety assessment are met, a safety evaluation will be performed describing 
demographics, pre-operative and surgical diagnosis (incl. hernia assessment), surgical 
procedure, adverse event, SSO, hernia recurrence and protocol deviations (if any). 
 
An interim analysis will be performed as soon as all subjects have documented the 3 
month visit or have withdrawn from the study earlier. All data will be analyzed based on 
the modified intention-to-treat (mITT) population (definition see below) until the 3 month 
visit. 
Unplanned interim analyses may also occur, for instance when all subjects have reached 
the 12 month follow-up visit. 
 
The Intention-to-treat (ITT) population consists of all enrolled subjects. The mITT 
population is defined as those subjects in the ITT population in whom Phasix Mesh has 
been implanted.  
 
A Per-Protocol (PP) population may be created if there are subjects who have any major 
protocol deviations. The PP population will consist of any subjects in the mITT 
population who do not have any major protocol deviation. The protocol deviations that 
are considered to have a “major” grade will be defined a priori in the SAP. All analyses 
will be primarily based on the mITT population. Primary analyses may be performed for 
PP population as well. 
 
Demographics and baseline characteristics will be summarized using the mITT 
population. Summary statistics for categorical variables will include frequency counts and 
percentages and for continuous variables mean, standard deviation, minimum, median 
and maximum. Subjects’ demographics and eligibility criteria (including reason for 
failure in case of screen failure) will be listed for the ITT set. 
 
The primary endpoint is the SSO rate up to (including) 3 months (± 14 days) post device 
placement based on the mITT population. A 95% confidence interval will be reported for 
the SSO rate.  
 
The SSO rate after 3 months post device placement, the hernia recurrence rates until 1, 3, 
6, 12, 18 and 24 months post device placement and surgical site infection rates until 1, 3, 
6, 12, 18 and 24 months post device placement will be reported by visit along with their 
95% confidence intervals based on the mITT population as secondary endpoints. 
Additionally, Kaplan-Meier analyses for the time from surgery to hernia recurrence and 
for the time from surgery to surgical site infection may be performed.  
 

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The secondary endpoints of VAS pain scale, Carolinas Comfort Scale® and EQ-5D™ will 
be summarized based on the mITT population with mean, standard deviation, minimum, 
median and maximum presented by visit. Device-related adverse events will tabulated by 
system organ class and preferred term (Medical dictionary for regulatory activities). The 
rate of subjects with a post procedure reoperation due to the index hernia repair will be 
presented by time intervals (until 1 month, 3 months, 6 months, 12 months, 18 months 
and until 24 months post device placement), Surgical procedure time of the index 
procedure (calculated as time of skin closure complete minus time of first incision) and 
length of hospital stay will be summarized descriptively. The time to return to work will 
be tabulated using summary statistics as well.  
Safety parameters, such as adverse events, device deficiencies (mechanical failure, 
malfunction or defects), physical examination and pain medication, will be summarized 
using the mITT population. 
 
Subgroup analyses will be performed by sex, sites (sites with few treated subjects can be 
combined) and other factors of interest. 
 
No missing value imputation methods will be applied in any of the aforementioned 
analyses. 
 
8. 
ADVERSE EVENTS 
 
The Investigator is responsible for the detection and documentation of events meeting the 
criteria and definition of an AE or SAE, as provided in this protocol. All AEs that occur 
during the study should be treated with established standards of care that will protect the 
life and health of the study subjects.   
 
AEs will be collected from the time of implantation (AE onset during or after index 
surgery) through the end of study participation (either study completion or early 
discontinuation) and will be documented in the medical record or source document and 
on eCRF.  All events will be followed to satisfactory resolution or stabilization.  
Events starting after ICF signature, but before implantation procedure will be documented 
as medical history in the medical record or source document and on eCRF. 
 
8.1. Definition of Adverse Event  
 
In this study, an AE is defined as any undesirable clinical event occurring in the 
abdominal space including the lower abdominal, inguinal and pubic regions (including 
the skin), as well as any other undesirable clinical events judged to be related to the study 
device or surgical procedure regardless of anatomical region. Additionally, abnormal 
laboratory results are to be considered AEs if the results are accompanied by clinical 
signs or symptoms.  The Investigator will assess the relationship of an AE to the study 
device or procedure as described in Section 8.5. 
 
8.2. Definition of Adverse Device Effect 
 
An Adverse Device Effect (ADE) is an AE related to the use of the mesh product 
implanted.  This includes AEs resulting from insufficient or inadequate IFU, deployment, 
implantation, installation, or operation, or any malfunction of the Phasix™ Mesh.  

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Additionally, this definition includes any event resulting from use error or from 
intentional misuse of the Phasix™ Mesh. 
 
8.3. Definition of Serious Adverse Event  
 
An event will be classified as a serious adverse event (SAE) if it meets the definition of 
serious in the ISO 14155:2011(E) as listed below: 
 
An adverse event is considered serious if it: 
a) led to a death, 
b) led to a serious deterioration in health that: 
1) resulted in a life-threatening illness or injury, or 
2) resulted in a permanent impairment of a body structure or a body function, or 
3) required in-patient hospitalization or prolongation of existing hospitalization, or 
4) resulted in 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: A planned hospitalization for pre-existing condition, or a procedure required by 
the Clinical Investigation Plan, without a serious deterioration in health, is not considered 
to be a serious adverse event. 
NOTE 2: For this study only Adverse Events according to the modified definition as per 
section 8.1 need to be collected in the eCRF. However, all Serious Adverse Events need 
to be reported, regardless of anatomical region or relatedness to surgical procedure or 
device. 
 
8.4. Serious Adverse Device Effect 
 
A Serious Adverse Device Effect (SADE) is an ADE that has resulted in any of the 
consequences characteristic of an SAE.  
 
8.5. Relationship of Adverse Event to Device/Procedure 
 
Assess each AE for its relationship to Phasix™ or surgical procedures as follows: 
 
• Device: This category should be restricted to AEs directly attributable 
to the device used as part of the study procedure. 
 
• Procedure:  This category should be restricted to AEs directly 
attributable to the study device surgical procedure.  
 

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Use the following categories for assigning the certainty of the relatedness: 
 
• Definitely Related:  An AE is definitely related if it is obvious, certain 
or there is little doubt regarding the relationship. 
 
• Possibly Related:  An AE is possibly related if it is capable of being 
related but relatively unlikely. 
 
• Not Related:  An AE is not related if it is determined that there is no 
plausible association. 
 
8.6. Severity of Adverse Events 
 
Each AE should be assessed for its severity, or the intensity of an event, experienced by 
the subject. 
 
• Mild:  Awareness of a sign or symptom that does not interfere with the subject’s 
activity or is transient and is resolved without treatment or sequelae. 
 
• Moderate:  May interfere with the subject’s activity and require additional 
intervention and/or treatment, and may have additional sequelae. 
 
• Severe:  Significant discomfort to the subject and/or interferes with the subject’s 
activity.  Additional intervention and/or treatment are necessary.  Additional 
sequelae occur.   
 
 
8.7. Reporting of Adverse Events 
 
If an AE occurs, all sections of the appropriate eCRF page must be completed. 
 
All Investigator-judged device-related AEs that occur (whether serious or not) must be 
reported to Davol Inc. Field Assurance within 24 hours of becoming aware of the event. 
 
Additionally, all SAEs (whether device- or procedure-related or not) must be reported to 
the Sponsor within 24 hours of becoming aware of the event.  
 
The Sponsor will report to the Food and Drug Administration (FDA) and to National 
Competent Authorities in Europe and other involved parties as per ISO 14155:2011(E) 
after becoming aware of a reportable event, as applicable per the corresponding national 
regulations.  
 
The provisions of Directive 93/42/EEC concerning information and notification of 
incidents occurring following placing devices on the market are fully applicable and 
remain with the investigator and manufacturer correspondingly.  
 
 
 
 

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9. 
SAFETY COMMITTEE 
 
The Safety Committee will consist of three members. The members will be selected on 
the basis of relevant experience and understanding of clinical research and the issues 
specific to the therapeutic area, as well as previous Safety Committee experience. 
Membership will be completely independent of the investigation and will have no 
financial, scientific, or other conflict of interest with the study, including the product used 
in this study.  
 
From the date of Phasix™ Mesh implant to each subject’s 3 month assessment visit, the 
following safety reassessment applies: 
 
If more than 4 device-related SAEs or more than 1 device-related recurrence occur(s): 
 
1. Enrollment and implantations are suspended until the impact of the study 
parameters (e.g., surgical technique, hernia size/mesh size, protocol deviations (if 
any), AE time-course) on the results is assessed. 
2. The follow-up for the subjects already treated continues. 
 
If the criteria for safety reassessment are met, the safety committee will evaluate the 
safety of the study protocol and decide about potential adaptations to the protocol and/or 
further enrollment. 
 
The further details of the Safety Committee will be documented in the Safety Committee 
Charter. 
 
10. 
DEVICE DEFICIENCY REPORTING AND MANAGEMENT 
 
All device deficiencies occurring during the conduct of this study will be reported by the 
Investigator to the Sponsor without unjustified delay. The further management of device 
deficiencies by the Investigator and the sponsor/manufacturer will adhere to the 
appropriate national laws and regulations. 
 
11. 
ELECTRONIC CASE REPORT FORMS  
 
The Investigator is responsible for ensuring the accuracy and completeness of all study 
documentation.  All clinical study data will be recorded in the eCRF provided to the 
investigational site.  
 
12. 
RISK/BENEFIT ANALYSIS 
 
Subjects participating in this study will require hernia repair surgery as part of their 
standard of care.  The device utilized in this study is commercially available, has 510(k) 
clearance from the US FDA, has a CE marking and will be used in accordance with the 
intended use as outlined in the IFU which is in place for the European market.  This study 
will not pose any additional potential risk to the health, safety, or welfare of the subject.  
The only additional risks posed by this study are related to data collection and the privacy 
of the patient’s personal health information. The risks associated with hernia repair and 
the mesh used in this clinical investigation are described in full in the corresponding IFU. 

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There is no immediate benefit to the subject for participation in this study.  Collection and 
analysis of the data generated in this study may be of benefit to future subjects who 
require hernia repair. 
 
13. 
DATA COLLECTION AND MONITORING 
13.1. Data collection 
 
The Investigator (or designated hospital staff) will assure primary data collection based 
on source-documented hospital chart reviews. 
 
13.1.1. Electronic Case Report Form (eCRF) 
 
All required clinical data for this trial will be collected in web-based standardized eCRFs. 
Site and subject numbers will be used to track subject information throughout the study. 
The eCRF is designed to accommodate the specific features of the study design. 
Modification of the eCRF will only be made if deemed necessary by Davol Inc. and/or 
the appropriate ethics committee (EC) and/or regulatory body. 
 
13.1.2. Monitoring 
 
Each site will have an initiation visit performed by a Study Monitor. This visit will ensure 
that the Investigator understands his/her responsibility for conducting this study at his/her 
center. 
Sites will be monitored according to the approved monitoring plan. Monitoring personnel 
will monitor for accuracy and timely submission of data forms and compliance with the 
study protocol, meeting enrollment commitments, applicable regulations, the signed 
Investigator Agreement and any conditions of approval imposed by the reviewing EC 
and/or regulatory agencies. 
 
The Study Monitors will maintain personal contact with the Investigator and staff 
throughout the study by phone, mail, and on-site visits. The Study Monitors will compile 
and submit to Davol Inc. a monitoring report after each visit that will include any 
findings, conclusions, and actions taken to correct deficiencies. 
 
13.1.3. Source Documentation 
 
Auditors, monitors, the study Sponsor and regulatory authorities may have access to the 
medical records related to this study. Original or certified copies of all relevant clinical 
findings, observations, and other activities throughout the clinical investigation must be 
recorded and maintained in the medical file of each enrolled subject. No source 
documentation will be recorded directly on an eCRF. The Investigator will permit study–
related monitoring, audits, EC review and authority inspections by allowing direct access 
to the source data. 
 
In case of electronic source data, access will be allowed or dated print-outs will be 
available prior to the monitoring visits.  
 

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13.1.4. Data Management 
 
Prior to enrollment of the first subject a Data Management Plan (DMP) will be developed 
outlining the procedures used for data review, database cleaning and issuing and 
resolving data queries. Procedures for validations and data storage will also be contained 
within the DMP. 
 
13.1.5. Record Retention 
 
The Sponsor and Investigator will maintain accurate, complete and current records 
relating to the conduct of the investigation according to national requirements. The data 
for some of these records may be available in computerized form from the CRO, but the 
final responsibility for maintaining study records remains with the Investigator. 
 
The investigator shall retain all study records for a period of at least 2 years after the 
investigation is terminated or completed. The investigator may withdraw from the 
responsibility to maintain records for the period required and transfer custody of the 
records to any other person who will accept responsibility for retaining them with pre-
approval.  Notice of a transfer shall be given to the Sponsor not later than 10 working 
days after transfer occurs. 
 
14. 
ADMINISTRATIVE REQUIREMENTS 
 
This study will be conducted in accordance with ISO 14155:2011, the Declaration of 
Helsinki in its currently recognized version, and any national and local regulations. 
 
14.1. Publication Policy  
 
Davol Inc. acknowledges that relevant study outcomes, positive or negative, must be 
made available to interested parties, especially physicians and regulators. In addition, this 
study will be posted on ClinicalTrials.gov and the Basic Results will be reported there, in 
accordance with applicable law.   
 
At the conclusion of the study, a multi-center article may be prepared for publication in a 
scientific journal. The publication of the principal results from any single-center 
experience is not allowed until the preparation and publication of the multi-center results 
as premature discussion of study data can give rise to real or perceived biases that can 
compromise the integrity of the study outcomes.  As such, exceptions to this rule require 
the prior approval of Davol Inc.   
 
For purposes of timely abstract presentation and publication, such publications will be 
delegated to the appropriate principal authors, and final analyses and manuscript review 
for all multi-center data will require the approval of Davol Inc. 
 
14.2. Investigator Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in 
relevant areas of clinical research and in the medical discipline investigated in this 
clinical study to ensure adherence to the requirements of the protocol, including the 

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protection of human subjects.  Other site personnel must have appropriate research 
experience and infrastructure to ensure adherence to the protocol and enrollment of 
sufficient numbers of evaluable subjects.  The curriculum vitae (CV) of the Investigator 
will be maintained in the Sponsor files as documentation of previous medical training, 
and federal databases will be searched to ensure that the Investigator and/or the site are 
not prohibited from engaging in federally Sponsored clinical research.  The Principal 
Investigator will sign the signature page of this protocol, agreeing to comply with all 
applicable government regulations and the requirements of this study. 
 
14.3. Regulatory and Ethical Considerations 
14.3.1. Ethics Committee Approval  
 
Investigators or designees must submit the study protocol together with all locally 
required documentation to their EC and obtain written favorable opinion before being 
allowed to participate in and conduct the study. Annual re-approval must also be 
obtained, if applicable per local regulation. The Investigator or designee is also 
responsible for fulfilling any conditions of approval imposed by the EC, such as regular 
safety reporting, study timing, etc. The Investigator or designee will provide Davol Inc. 
with copies of such approvals and reports. 
 
Any amendments to the protocol, as well as possible associated information and consent 
form changes, will be submitted to the EC and written favorable opinion obtained prior to 
implementation, as required per national laws and regulations. 
 
14.3.2. Authorization from / notification to competent authority 
 
National competent authorities will be sought authorization from or will be notified on 
the conduct of this study in accordance with the requirements of the applicable national 
laws and regulations. 
 
Any amendments to the protocol, as well as possible associated information and consent 
form changes, will be notified to, or approved by the national competent authorities, if 
required. 
 
14.3.3. Informed Consent  
 
Prior to the procedure, the Investigator (or designee) must explain to each subject in 
layman’s terms, the nature of the study, its purpose, expected duration, and the benefits 
and risks of study participation. Also, subjects will be informed of uses and disclosures of 
their medical information for research purposes and their rights to access information 
about them. The subjects must be informed of their rights to withdraw from the study at 
any time for any reason without sanction, penalty, or loss of benefits to which they are 
otherwise entitled, and that withdrawal from the study will not jeopardize their future 
medical care.  After this explanation and before entering the study, the subject must 
voluntarily sign and date the EC-approved ICF. The subject will receive a copy of their 
ICF.  
 
If, during the course of the study, new information becomes available that might affect 
the subjects’ or otherwise take influence on the subjects’ continued willingness of 

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participation in this clinical study, they will be informed thereof in accordance with the 
procedures described above for obtaining their informed consent. Subjects should be re-
consented in such a situation. 
 
 
14.3.4. Confidentiality 
 
All information and data sent to Davol Inc. or an authorized designee concerning subjects 
or their participation in the study will be considered confidential. All data used in the 
analysis and reporting of this study will be used in a manner without identifiable 
reference to the subject. The Investigator consents to visits by personnel of Davol Inc. and 
its affiliates or designees, as well as, FDA representatives. 
 
14.4. Protocol Adherence, Deviations and Amendments 
 
A protocol deviation is defined as an event where the clinical Investigator or site 
personnel did not conduct the study according to the Investigational Plan.  
It is the Investigator’s responsibility to ensure that there are no deviations from the 
investigational plan except where necessary to protect the life or physical well-being of a 
subject in an emergency. Continued protocol deviations may result in termination of 
enrollment in the study at the site.  
 
Deviations must be reported within the eCRF regardless of whether medically justifiable 
or taken to protect the subject in an emergency. Investigators will also adhere to 
procedures for reporting study deviations to their EC in accordance with their specific EC 
reporting policies and procedures. 
 
 
14.5. Device Accountability 
 
Only commercially available surgical mesh products will be used. Device accountability 
will not be required.  
 
14.6. Subject Compensation 
 
Subjects will be reimbursed at a fixed rate to cover their travel costs to the clinic for each 
on-site follow-up visit that they complete.  
 
15. 
TERMINATION OF STUDY  
 
Sponsor reserves the right to suspend enrollment or terminate the study at any time as set 
forth in the Clinical Study Agreement.  Written notice will be submitted to the 
Investigator in advance of such termination. 
 
Sponsor may suspend enrollment or terminate the study at a specific site for reasons 
including, but not limited to, inadequate data collection, low subject enrollment rate, 
achievement of the total enrollment, or non-compliance with the protocol or other clinical 
research requirements. 
 
 

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16. 
STATEMENT OF COMPLIANCE 
 
This clinical investigation will be conducted in compliance with the clinical investigation 
plan (CIP) and the following regulatory requirements: 
 
• International Standard ISO 14155:2011: Clinical investigation of medical devices for 
human subjects - Good clinical practice (GCP) 
• Declaration of Helsinki adopted by the 18thWorld Medical Assembly in Helsinki, 
Finland, in 1964, in its currently recognized revision 
• Applicable sections of the national laws and regulations. 
 
By acting in accordance with this CIP, the Sponsor, the Investigators and the study site 
personnel fulfill the requirements of the International Standard ISO 14155:2011. 
 
The clinical investigation will not commence at a clinical site until favorable opinion(s) 
from the respective ethics committee(s) (ECs) have been received. All additional 
requirements imposed by the EC(s) will be followed. Involvement of the national 
competent authorities, e.g. by notification, seeking authorization, will be accomplished as 
required by national laws and regulations. 
 
Insurance coverage for damages emerging from the clinical investigation will be provided 
according to applicable legal requirements. 

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17. 
REFERENCES 
 
1. Hoer J, Lawong G, Klinge U, Schumpelick V. Factors influencing the 
development if incisional hernia. A retrospective study of 2983 laparotomy 
patients over a period of 10 years [Article in German]. Chirurg. 2002 May; 
73(5):474-80. 
 
2. Cobb W, Kercherk, Heniford B. Laparoscopic repair of incisional hernias. The 
Surgical Clinics of North America 2005; 85: 91 – 103. 
 
3. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, 
IJzermans JN, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC, 
Bruijninckx CM, Jeekel J A comparison of suture repair with mesh repair for 
incisional hernia. N Engl J Med 2000; 343:392–398. 
 
4. Burger JWA, Luijendijk RW, Hop WCJ, Halm JA, Verdaasdonk EGG, Jeekel J.. 
Long-term follow-up of a randomized controlled trial of suture versus mesh repair 
of incisional hernia. Ann Surg 2004; 240(4):578–85. 
 
5. van Geffen H, Simmermacher R, van Vroonhoven T, van der Werken C. Surgical 
treatment of large contaminated abdominal wall defects. J Am Coll Surg 2005; 
201: 206 – 212. 
 
6. Ramirez RM, Ruas E, Dellon AL. “Components separation method for closure of 
abdominal-wall defects: An anatomic and clinical study. Plast Reconstr Surg 
1990; 86:519 – 526. 
 
7. DiBello J, Moore J. Sliding myofascial flap of the rectus abdominis muscle for the 
closure of recurrent ventral hernias. Plast Reconstr Surg 1996; 98:464 – 469. 
 
8. Girotto J, Ko M, Redett, et al. Closure of chronic abdominal wall defects: a long-
term evaluation of the component separation method. Ann Plast Surg 1999; 
42:385 – 395. 
 
9. Shestak K, Edington H, Johnson R. The separation of anatomical components 
technique for the reconstruction of massive midline abdominal wall defects: 
anatomy, surgical technique, application and limitations revisited. Plast Reconstr 
Surg 2000; 105:731- 738. 
 
10. Lowe J, Garza J, Bowman J, et al. Endoscopically assisted “components 
separation technique” for closure of abdominal wall defects. Plast Reconstr Surg 
2000; 105:720 – 729. 
 
11. Markar SR, Karthikesalingam A, Alam F, Tang TY, Walsh SR, Sadat U. Partially 
or completely absorbable versus nonabsorbable mesh repair for inguinal hernia: a 
systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2010 
Aug; 20(4):213-9. Review. PubMed PMID: 20729687. 
 
12. Hakeem A, Shanmugam V.  Inguinodynia following Lichtenstein tension-free 
hernia repair: A review. World J Gastroenterol. 2011; 17(14):1791-1796. 

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13. Sadowski B, Rodriguez J, Symmonds R, Roberts J, Song J, Rajab MH, Cummings 
C, Hodges B; The Scott and White Outcomes and Effectiveness Registry Group.  
Comparison of polypropylene versus polyester mesh in the Lichtenstein hernia 
repair with respect to chronic pain and discomfort.  Hernia. Published online: 14 
July 2011.  Doi: 10.1007/s10029-011-0841-x.  
 
14. Martin DP, Williams SF.  Medical applications of poly-4-hydroxybutyrate: a 
strong flexible absorbable biomaterial.  Biochemical Engineering Journal 
2003;16:97-105.  
 
15. Chen GQ, Wu Q. The application of polyhydroxyalkanoates as tissue engineering 
materials. Biomaterials. 2005 Nov26; 33:6565-78.  
 
16. Wu Q, Wang Y, Chen GQ.  Medical application of Microbial Biopolyesters 
Polyhydroxyalkanoates.  Artificial Cells, Blood Substitutes, and Biotechnology 
2009; 37:1-12. 
 
17. CDC Surgical Site Infection (SSI) Event Protocol  [cited on 2015 Jun 19]; 
Available from: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf 
 
 
 
 
 

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18. 
APPENDIX 
18.1. Appendix A: Surgical Site Infection Criteria17 
 
Superficial Incisional Surgical Site Infections (SSI)  
Infection occurs within 30 days after the operative procedure (where day 1 = procedure 
day) 
AND 
involves only the skin or subcutaneous tissue of the incision  
AND  
at least one of the following: 
A. Purulent drainage from the superficial incision or subcutaneous tissue. 
B. Organisms isolated from an aseptically obtained culture of fluid or tissue from the 
superficial incision. 
C. Superficial incision that is deliberately opened by a surgeon, attending physician 
or other designee and is culture positive or not cultured 
AND 
Patient has at least one of the following signs or symptoms: pain or tenderness; 
localized swelling; erythema; or heat. A culture negative finding does not meet 
this criterion. 
D. Diagnosis of a superficial incisional SSI by the surgeon or attending physician or 
other designee. 
 
COMMENT: There are two specific types of superficial incisional SSIs: 
1. Superficial Incisional Primary (SIP) –a superficial incisional SSI that is identified in 
the primary incision in a patient that has had an operation with one or more 
incisions (e.g., C -section incision or chest incision for CBGB) 
2. Superficial Incisional Secondary (SIS) – a superficial incisional SSI that is 
identified in the secondary incision in a patient that has had an operation with more 
than one incision (e.g., donor site incision for CBGB) 
 
The following do not qualify as criteria for meeting the definition of superficial SSI: 
• Diagnosis/treatment of cellulitis (redness/warmth/swelling), by itself, does not 
meet criterion d for superficial incisional SSI.  An incision that is draining or 
culture (+) is not considered a cellulitis. 
• A stitch abscess alone (minimal inflammation and discharge confined to the points 
of suture penetration). 
 
- 
Deep Incisional SSI 
Infection occurs within 90 days after the operative procedure (for herniorrhaphy) (where 
day 1 = procedure day)   
AND 
involves deep soft tissues of the incision (e.g., fascia and muscle layers)  
AND 
patient has at least one of the following: 
a. Purulent drainage from the deep incision. 
b. A deep incision spontaneously dehisces or is deliberately opened or aspirated by a 
surgeon, attending physician or other designee and is culture positive or not 
cultured 
AND 

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patient has at least one of the following signs or symptoms:  fever (>38°C), 
localized pain or tenderness.  A culture negative finding does not meet this 
criterion. 
c. An abscess or other evidence of infection involving the deep incision that is 
detected on gross anatomical or histopathologic exam, or imaging test. 
 
COMMENTS: There are two specific types of deep incisional SSIs: 
 
1.  Deep Incisional Primary (DIP) –a deep incisional SSI that is identified in a primary 
incision in a patient that has had an operation with one or more incisions (e.g., C-
section incision or chest incision for CBGB) 
2.  Deep Incisional Secondary (DIS) – a deep incisional SSI that is identified in the 
secondary incision in a patient that has had an operation with more than one incision 
(e.g., donor site incision for CBGB) 
 
- 
Organ/Space SSI 
Must meet the following criteria: 
Infection occurs within 90 days after the operative procedure (for herniorrhaphy)(where 
day 1 = procedure day)   
AND 
infection involves any part of the body deeper than the fascial/muscle layers, that is 
opened or manipulated during the operative procedure 
AND 
patient has at least one of the following: 
a.   purulent drainage from a drain that is placed into the organ/space (e.g., closed 
suction drainage system, open drain, T-tube drain, CT guided drainage) 
b.  organisms isolated from an aseptically-obtained culture of fluid or tissue in the 
organ/space 
c.   an abscess or other evidence of infection involving the organ/space that is 
detected on gross anatomical or histopathologic exam, or imaging test 
AND 
meets at least one of the organ/space infection site “intraabdominal” criteria: 
1. Patient has organisms cultured from abscess and/or purulent material from 
intraabdominal space. 
2. Patient has abscess or other evidence of intraabdominal infection on gross 
anatomic or 
histopathologic exam. 
3. Patient has at least two of the following signs or symptoms: fever (>38.0°C±), 
nausea*,   vomiting*, abdominal pain*, or jaundice*  
AND 
at least one of the following: 
a. organisms seen on culture or Gram stain of drainage or tissue obtained 
during invasive procedure or from an aseptically-placed drain (e.g., closed 
suction drainage system, open drain, T-tube drain, CT guided drainage) 
b. organisms cultured from blood and imaging test evidence suggestive of 
infection (e.g., ultrasound, CT scan, MRI, radiolabel scans [gallium, 
technetium, etc.] or on abdominal x-ray), which if equivocal is supported 
by clinical correlation. 
* With no other recognized cause 
± As documented in the medical record