| NCT ID | NCT04718168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | Hernia, Ventral |
| Study Type | INTERVENTIONAL |
| Enrollment | 245 participants |
| Start Date | 2021-05-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 245 participants in total. It began in 2021-05-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Pre-procedure Inclusion Criteria: The subject is / has: 1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable). 2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system. 3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement. 4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system. 5. Willing to provide informed consent and comply with follow-up requirements. Pre-procedure Exclusion Criteria: The subject is / has: 1. Treated in another drug or medical device study within 1 year of study enrollment. 2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects. 3. 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). 4. A BMI \>40. 5. Evidence of a systemic infection. 6. Cirrhosis or undergoing dialysis. 7. A wound-healing disorder. 8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy. 9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure. 10. A stoma. 11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements. 12. Positive pregnancy or lactation status as confirmed by site standard of care. 13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices. Post-procedure Inclusion Criteria At the time of index procedure, the subject is / has: 1. At least 18 years old. Minimum age required by state regulations (as applicable). 2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date. 3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject. Post-procedure Exclusion Criteria At the time of index procedure, the subject is / has: 1. Treated in another drug or medical device study within 1 year of study enrollment. 2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects. 3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device). 4. A BMI \>40. 5. Evidence of a systemic infection. 6. Cirrhosis or undergoing dialysis. 7. A wound-healing disorder. 8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy. 9. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure. 10. A stoma. 11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements. 12. Positive pregnancy or lactation status as confirmed by site standard of care. 13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
Contact & Investigator
Todd Heniford, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT04718168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hernia, Ventral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04718168 currently recruiting?
Yes, NCT04718168 is actively recruiting participants. Contact the research team at ENF1806@wlgore.com for enrollment information.
Where is the NCT04718168 trial being conducted?
This trial is being conducted at San Diego, United States, Denver, United States, Sarasota, United States, Evanston, United States and 5 additional locations.
Who is sponsoring the NCT04718168 clinical trial?
NCT04718168 is sponsored by W.L.Gore & Associates. The principal investigator is Todd Heniford, MD at Wake Forest University Health Sciences. The trial plans to enroll 245 participants.