Study of GORE4 ENFORM Biomaterial Device Performance in Ventral and Hiatal Hernia Repairs

What this Trial Is About

Researchers are conducting a prospective and retrospective, non-randomized, multicenter study to gather real-world data on the performance and patient experience of the GORE ENFORM Biomaterial device used in hernia repairs. The study involves two separate hernia groups one for ventralincisional hernia repair and another for diaphragmatichiatal hernia repair. The main goal is to evaluate the devices functional performance and monitor outcomes over the long term. Participants will receive the GORE ENFORM Biomaterial device in one of two forms preperitoneal or intraperitoneal bioabsorbable hernia mesh. The study groups are divided based on the type of hernia repair ventralincisional or hiataldiaphragmatic and the device placement location. The study collects data from commercial use of the device without randomization, following patients treated with these mesh devices for up to 24 months. During the study, participants will be monitored for hernia recurrence, surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention primarily within the first 45 days after surgery and up to 24 months afterward. Quality of life and symptom relief, including gastroesophageal reflux disease symptoms, will also be assessed. Data collection includes both short-term procedural outcomes and long-term safety and effectiveness, with follow-up lasting up to two years after device implantation.

GORE® ENFORM Biomaterial Product Study