NCT04718168

GORE® ENFORM Biomaterial Product Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 long-term follow up.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Gore ENFORM Biomaterial (Preperitoneal)	ENFORM Biomaterial bioabsorbable hernia mesh
DEVICE	Gore ENFORM Biomaterial (Intraperitoneal)	ENFORM Biomaterial bioabsorbable hernia mesh

Timeline

• Start date: 2021-05-17
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-01-22
• Last updated: 2026-02-18

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study