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RecruitingNot ApplicableNCT04718168

GORE® ENFORM Biomaterial Product Study

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

Sponsor

W.L.Gore & Associates

Enrollment

245 participants

Start Date

May 17, 2021

Study Type

INTERVENTIONAL

Conditions

Incisional HerniaHernia, VentralHernia, HiatalHernia, Diaphragmatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Gore ENFORM Biomaterial (Intraperitoneal) and a medical device called Gore ENFORM Biomaterial (Preperitoneal) for people with hernia, diaphragmatic, hernia, hiatal, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGore ENFORM Biomaterial (Preperitoneal)

ENFORM Biomaterial bioabsorbable hernia mesh

DEVICEGore ENFORM Biomaterial (Intraperitoneal)

ENFORM Biomaterial bioabsorbable hernia mesh

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

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NCT04718168

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