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

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 study is tracking outcomes for patients who have had hernia repair surgery using a specific surgical mesh product called GORE ENFORM Biomaterial. This is a post-market registry study — meaning the device is already approved for clinical use, and the study is collecting real-world data on how well it performs over time for ventral (abdominal wall) or hiatal (diaphragm) hernia repairs. Participants will be followed over time to measure hernia recurrence rates, complication rates, and recovery outcomes. Some participants are enrolled before surgery; others are enrolled after surgery using the same device, with their prior records reviewed retrospectively. You may be eligible if... - You are 18 years of age or older - You are having (or had) a single-site ventral or hiatal hernia repair using GORE ENFORM Biomaterial - Your hernia is a clean (Class I) surgical wound and Grade 1 or 2 severity - Your BMI is 40 or under - You are willing to attend follow-up visits You may NOT be eligible if... - You have a systemic infection, cirrhosis, or kidney failure requiring dialysis - You are pregnant or breastfeeding - You are immunocompromised (HIV, organ transplant, chemotherapy or radiation) - You have a wound-healing disorder or a stoma - Your BMI is above 40 Talk to your doctor to see if this trial is right for you.

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

View Full Details on ClinicalTrials.gov

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NCT04718168


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