Clinical Trials in the USA / NCT04718168
Recruiting
Not applicable
GORE® ENFORM Biomaterial Product Study
NCT04718168 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hernia, VentralHernia, HiatalHernia, DiaphragmaticIncisional Hernia
Investigational drug(s) / intervention(s)
Gore ENFORM Biomaterial (Preperitoneal)Gore ENFORM Biomaterial (Intraperitoneal)
Gore ENFORM Biomaterial (Preperitoneal): ENFORM Biomaterial bioabsorbable hernia mesh
Gore ENFORM Biomaterial (Intraperitoneal): ENFORM Biomaterial bioabsorbable hernia mesh
Study 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
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.
Primary outcome measure(s)
- Hernia Recurrence - Primary Device Endpoint — Through 24 months
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure). - Incidence of SSI - Primary Procedural Endpoint 1 — First Post-Procedural Visit (Days 1-45)
Incidence of SSI, reported as a composite and individually. - Incidence of SSO - Primary Procedural Endpoint 2 — First Post-Procedural Visit (Days 1-45)
Incidence of SSO, reported as a composite and individually. - Incidence of SSOPI - Primary Procedural Endpoint 3 — First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI, reported as a composite and individually.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California - San Diego | San Diego | California | Recruiting |
| Institute of Esophageal and Reflux Surgery | Denver | Colorado | Recruiting |
| Sarasota Memorial HealthCare System | Sarasota | Florida | Completed |
| Northshore University Health System Research Institute | Evanston | Illinois | Recruiting |
| University of Kentucky | Lexington | Kentucky | Recruiting |
| Atrium Health | Charlotte | North Carolina | Completed |
| Prisma Health - Upstate | Greenville | South Carolina | Recruiting |
| University of Texas Health Science Center at Houson | Houston | Texas | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More W.L.Gore & Associates trials in the USA
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04718168 on ClinicalTrials.gov ↗ ← All trials in the USA