Post-market Study of the Biodesign Hernia Graft

RecruitingOBSERVATIONAL
Enrollment

95

Participants

Timeline

Start Date

November 10, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Ventral Hernia
Interventions
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.

Trial Locations (3)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

V6Z 1Y6

RECRUITING

St. Paul's Hospital, Vancouver

B3H 2Y9

RECRUITING

Queen Elizabeth II Hospital, Halifax

Sponsors
All Listed Sponsors
lead

Cook Biotech Incorporated

INDUSTRY

NCT04294446 - Post-market Study of the Biodesign Hernia Graft | Biotech Hunter | Biotech Hunter