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GORE® ENFORM Biomaterial Product Study | Clinical Trials | Clareo Health

RECRUITINGNA

GORE® ENFORM Biomaterial Product Study

GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients

NCT04718168•W.L.Gore & Associates

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.

Detailed Description

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject is / has:
•1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
•2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
•3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
•4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
•5. Willing to provide informed consent and comply with follow-up requirements.
•At the time of index procedure, the subject is / has:
•1. At least 18 years old. Minimum age required by state regulations (as applicable).
•2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.
•3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.

Exclusion Criteria

•The subject is / has:
•1. Treated in another drug or medical device study within 1 year of study enrollment.
•2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
•3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
•4. A BMI \>40.
•5. Evidence of a systemic infection.
•6. Cirrhosis or undergoing dialysis.
•7. A wound-healing disorder.
•8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
•9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
+18 more criteria

Locations (9)

University of California - San Diego

San Diego, California, United States

Institute of Esophageal and Reflux Surgery

Denver, Colorado, United States

Sarasota Memorial HealthCare System

Sarasota, Florida, United States

Northshore University Health System Research Institute

Evanston, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Atrium Health

Charlotte, North Carolina, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

University of Texas Health Science Center at Houson

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

May 17, 2021

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

February 18, 2026

Enrollment

245

ESTIMATED participants

Conditions

Hernia, VentralHernia, HiatalHernia, DiaphragmaticIncisional Hernia

Interventions

Gore ENFORM Biomaterial (Preperitoneal)

DEVICE

Gore ENFORM Biomaterial (Intraperitoneal)

DEVICE

Contacts

Shelli Ryczek

CONTACT

928 864 3640 ENF1806@wlgore.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GORE® ENFORM Biomaterial Product Study

Inclusion Criteria

Exclusion Criteria

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Fetoscopic Endoluminal Tracheal Occlusion

Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation

Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia

Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair