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GORE® ENFORM Biomaterial Product Study

Study acronym: ENF 18-06
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 2 of 9 sitesv12
  2. Re-verified, no change to tracked fieldsv11
  3. Study description expanded, about 46 words
    • Site details revised at 4 of 9 sites
    v10
  4. Primary completion date: Jan 2025 to Sep 2026
    • Study sites: 5 to 9
    • Study completion date: Apr 2025 to Sep 2026
    v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 233 wordsv7
  2. Study sites: 4 to 5v6
  3. Enrollment target: 400 to 245
    • Primary endpoints: 3 to 4
    • Study sites: 3 to 4
    • Eligibility criteria expanded, about 45 words
    v5
  4. Study sites: 2 to 3v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 2021 to May 17, 2021
    v3
  6. Primary completion date: Jun 2024 to Jan 2025v2 Show 4 more changesShow less
    • Start date: Jan 2021 to Apr 2021
    • Study completion date: Sep 2024 to Apr 2025
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description shortened, about 90 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04718168
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
Related terms Hernia, Hernia, Diaphragmatic, Hernia, Hiatal, Hernia, Ventral, Incisional Hernia, Surgical Wound
Enrollment 245 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov