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GORE® ENFORM Biomaterial Product Study

NCT04718168 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-02-18

No results posted yet for this 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

  • Hernia, Ventral
  • Hernia, Hiatal
  • Hernia, Diaphragmatic
  • Incisional Hernia

Interventions

DEVICE

Gore ENFORM Biomaterial (Preperitoneal)

ENFORM Biomaterial bioabsorbable hernia mesh

DEVICE

Gore ENFORM Biomaterial (Intraperitoneal)

ENFORM Biomaterial bioabsorbable hernia mesh

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Todd Heniford, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718168 on ClinicalTrials.gov