Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04718168

GORE® ENFORM Biomaterial Product Study

Led by W.L.Gore & Associates · Updated on 2026-02-18

245

Participants Needed

9

Research Sites

276 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

GORE® ENFORM Biomaterial Product Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old at the time of informed consent
  • Expected Class I (Clean) surgical wound using CDC Surgical Wound Classification system
  • Planned implant with GORE4 ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement
  • Expected Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system
  • Willing to provide informed consent and comply with follow-up requirements
  • Implanted with GORE4 ENFORM Biomaterial for a single site ventral or hiatal hernia repair on or before 365 days prior to site protocol amendment 3 approval date
  • Signed informed consent form unless waived by Institutional Review Board
Not Eligible

You will not qualify if you...

  • Treated in another drug or medical device study within 1 year of enrollment
  • Implanted with GORE4 ENFORM Biomaterial for cardiovascular defect reconstruction
  • Hernia repair expected as part of a bridged procedure requiring permanent device support
  • Body mass index (BMI) greater than 40
  • Evidence of a systemic infection
  • Cirrhosis or undergoing dialysis
  • Wound-healing disorder
  • Immunocompromised status (e.g., HIV, transplant, chemotherapy, radiation therapy)
  • Mesh implantation combined with bariatric or panniculectomy procedures
  • Presence of a stoma
  • Co-morbid conditions limiting compliance with study or follow-up
  • Positive pregnancy or lactation status confirmed by standard care
  • Hernias needing treatment in multiple body regions or requiring multiple mesh devices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University of California - San Diego

San Diego, California, United States, 92093

Actively Recruiting

2

Institute of Esophageal and Reflux Surgery

Denver, Colorado, United States, 80124

Actively Recruiting

3

Sarasota Memorial HealthCare System

Sarasota, Florida, United States, 34239

Actively Recruiting

4

Northshore University Health System Research Institute

Evanston, Illinois, United States, 60201

Actively Recruiting

5

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

6

Atrium Health

Charlotte, North Carolina, United States, 28204

Actively Recruiting

7

Prisma Health - Upstate

Greenville, South Carolina, United States, 29615

Actively Recruiting

8

University of Texas Health Science Center at Houson

Houston, Texas, United States, 77401

Actively Recruiting

9

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

S

Shelli Ryczek

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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GORE® ENFORM Biomaterial Product Study | DecenTrialz