NCT04294446

Post-market Study of the Biodesign Hernia Graft

Post-market Study of the Biodesign® Hernia Graft

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Cook Biotech Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Detailed description

This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair. This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site. This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Biodesign Hernia Graft	The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.

Timeline

• Start date: 2020-11-10
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2020-03-04
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study