GORE® ENFORM Biomaterial Product Study
ENF 18-06
1 other identifier
interventional
245
1 country
9
Brief Summary
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 18, 2026
February 1, 2026
5.3 years
August 24, 2020
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hernia Recurrence - Primary Device Endpoint
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Through 24 months
Incidence of SSI - Primary Procedural Endpoint 1
Incidence of SSI, reported as a composite and individually.
First Post-Procedural Visit (Days 1-45)
Incidence of SSO - Primary Procedural Endpoint 2
Incidence of SSO, reported as a composite and individually.
First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI - Primary Procedural Endpoint 3
Incidence of SSOPI, reported as a composite and individually.
First Post-Procedural Visit (Days 1-45)
Secondary Outcomes (4)
Freedom from potential device-related SAEs - Secondary endpoint 1
Through 24 months
Re-intervention at study-treated location - Secondary Endpoint 2
Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
Through 24 months
Relief from GERD Symptoms - Secondary Endpoint 4
Through 24 months
Study Arms (4)
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
EXPERIMENTALVentral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
EXPERIMENTALHiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
EXPERIMENTALHiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
EXPERIMENTALInterventions
ENFORM Biomaterial bioabsorbable hernia mesh
ENFORM Biomaterial bioabsorbable hernia mesh
Eligibility Criteria
You may qualify if:
- The subject is / has:
- At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
- An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
- A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
- An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
- Willing to provide informed consent and comply with follow-up requirements.
You may not qualify if:
- The subject is / has:
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
- A BMI \>40.
- Evidence of a systemic infection.
- Cirrhosis or undergoing dialysis.
- A wound-healing disorder.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
- At the time of index procedure, the subject is / has:
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of California - San Diego
San Diego, California, 92093, United States
Institute of Esophageal and Reflux Surgery
Denver, Colorado, 80124, United States
Sarasota Memorial HealthCare System
Sarasota, Florida, 34239, United States
Northshore University Health System Research Institute
Evanston, Illinois, 60201, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Prisma Health - Upstate
Greenville, South Carolina, 29615, United States
University of Texas Health Science Center at Houson
Houston, Texas, 77401, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Heniford, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2020
First Posted
January 22, 2021
Study Start
May 17, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share