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NCT04718168 · ClinicalTrials.gov registry record · NA
GORE® ENFORM Biomaterial Product Study
A NA study of Hernia, Ventral and Incisional Hernia, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 245
- Enrollment target
- 9
- Study locations
NCT04718168: Recruiting NA study of Hernia, Ventral and Incisional Hernia, sponsored by W.L.Gore & Associates.
NCT04718168 is a NA study of Hernia, Ventral and Incisional Hernia that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 245 participants, above the 148-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (66% higher). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04718168, a NA study of Hernia, Ventral and Incisional Hernia, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Conditions Studied
Interventions
- DEVICE Gore ENFORM Biomaterial (Preperitoneal)
- DEVICE Gore ENFORM Biomaterial (Intraperitoneal)
Study Locations (9)
California
- University of California - San Diego - San Diego
Colorado
- Institute of Esophageal and Reflux Surgery - Denver
Florida
- Sarasota Memorial HealthCare System - Sarasota
Illinois
- Northshore University Health System Research Institute - Evanston
Kentucky
- University of Kentucky - Lexington
North Carolina
- Atrium Health - Charlotte
South Carolina
- Prisma Health - Upstate - Greenville
Texas
- University of Texas Health Science Center at Houson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT04718168 shows while recruiting
NCT04718168 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 148-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (66% higher).
The record links to 4 conditions, with Hernia, Ventral appearing as the primary indexed condition, and to 2 interventions - of which Gore ENFORM Biomaterial (Preperitoneal) is the first listed.
NCT04718168 lists 9 locations in 9 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT04718168 about?
NCT04718168 is a clinical study titled "GORE® ENFORM Biomaterial Product Study". 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 fu...
What is the current status of trial NCT04718168?
This trial is currently recruiting. It is a NA study. The enrollment target is 245 participants. The study started on 2021-05-17. Estimated completion is 2026-09.
What conditions does trial NCT04718168 study?
This clinical trial studies the following conditions: Hernia, Ventral, Incisional Hernia, Hernia, Hiatal, Hernia, Diaphragmatic.
What interventions are being tested in trial NCT04718168?
The interventions under investigation include: Gore ENFORM Biomaterial (Preperitoneal) (DEVICE), Gore ENFORM Biomaterial (Intraperitoneal) (DEVICE).
Who is sponsoring clinical trial NCT04718168?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04718168 being conducted?
This trial has 9 study locations across California, Colorado, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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