GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Pre-procedure 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. Pre-procedure Exc…
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 DiegoSan Diego, California
- Institute of Esophageal and Reflux SurgeryDenver, Colorado
- Sarasota Memorial HealthCare SystemSarasota, Florida
- Northshore University Health System Research InstituteEvanston, Illinois
- University of KentuckyLexington, Kentucky
- Atrium HealthCharlotte, North Carolina