Clinical Trial

GORE® ENFORM Biomaterial Product Study

Study acronym: ENF 18-06
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-01-15; most recent amendment 2026-02-17.
Status change: Not Yet Recruiting → Recruiting 2021-07-12
Trial Details
NCT Number NCT04718168
Lead Sponsor W.L.Gore & Associates
Conditions Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
Enrollment 245 participants
Start Date 2021-05-17
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-30