Actively Recruiting
GORE4 ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
Led by W.L.Gore & Associates · Updated on 2026-02-18
245
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the performance of the GORE4 ENFORM Biomaterial device in patients undergoing hernia repair surgery. This multicenter, non-randomized study includes two separate groups of patients: those with ventral or incisional hernias and those with diaphragmatic or hiatal hernias. The main goal is to collect data on how well the device functions and to observe patient outcomes over time. The study evaluates two types of the GORE4 ENFORM Biomaterial hernia mesh, used either preperitoneally or intraperitoneally, to support hernia repair surgeries. Patients receive the device during planned hernia repair procedures, with the study following their progress both shortly after surgery and for up to 24 months. The study does not involve random assignment but observes patients treated with the device in routine clinical care. Participants will be monitored through follow-up visits to assess hernia recurrence and complications such as surgical site infections or other related issues within the first 45 days after surgery. Additional long-term assessments include checking for serious adverse events, need for further procedures, quality of life changes, and relief from symptoms like acid reflux. Data collection continues for up to two years to provide a comprehensive view of patient experience and device performance.
CONDITIONS
Brief Title
GORE® ENFORM Biomaterial Product Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of informed consent
- Expected to have a clean (Class I) surgical wound
- Planned implant with GORE4 ENFORM Biomaterial for single site ventral or hiatal hernia repair
- Expected to have Grade 1 or Grade 2 ventral hernia
- Willing to provide informed consent and comply with follow-up requirements
You will not qualify if you...
- Participation in another drug or medical device study within 1 year
- Use of GORE4 ENFORM Biomaterial for cardiovascular reconstruction
- Hernia repair as part of a bridged procedure requiring permanent device support
- Body mass index (BMI) greater than 40
- Evidence of systemic infection
- Cirrhosis or dialysis treatment
- Wound-healing disorders
- Immunocompromised conditions including HIV, transplant, chemotherapy, or radiation
- Hernia repair combined with bariatric or panniculectomy procedures
- Presence of a stoma
- Co-morbid conditions limiting study compliance
- Pregnancy or lactation
- Hernias requiring treatment in multiple body regions or use of multiple mesh devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 45 days post-procedure
Participants undergo hernia repair surgery using the GORE® ENFORM Biomaterial device and receive immediate post-operative care.
1 to 2 visits within 45 days after surgery
Duration - Through 24 months
Participants are followed long-term to assess device performance and health outcomes after surgery.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 9 locations
1
University of California - San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
Institute of Esophageal and Reflux Surgery
Denver, Colorado, United States, 80124
Actively Recruiting
3
Sarasota Memorial HealthCare System
Sarasota, Florida, United States, 34239
Actively Recruiting
4
Northshore University Health System Research Institute
Evanston, Illinois, United States, 60201
Actively Recruiting
5
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
6
Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
7
Prisma Health - Upstate
Greenville, South Carolina, United States, 29615
Actively Recruiting
8
University of Texas Health Science Center at Houson
Houston, Texas, United States, 77401
Actively Recruiting
9
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Shelli Ryczek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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