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GORE® ENFORM Biomaterial Product Study
NCT04718168 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04718168
The ClinicalTrials.gov registry entry for NCT04718168 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04718168 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04718168?
The interventions under investigation include: Gore ENFORM Biomaterial (Preperitoneal) (DEVICE), Gore ENFORM Biomaterial (Intraperitoneal) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04718168?
This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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