Post-market Study of the Biodesign Hernia Graft

Cook Group

Status: Enrolling

Conditions: Ventral Hernia

Treatments: Device: Biodesign Hernia Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT04294446

19-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft

Exclusion criteria

1. Known sensitivity to porcine material

   For the study, the following patients will also be excluded:

2. Age < 18 years

3. Unable or unwilling to provide informed consent

4. Life expectancy of less than one year from the date of the index procedure

5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.