Post-market Study of the Biodesign Hernia Graft

Last updated: December 12, 2024
Sponsor: Cook Biotech Incorporated
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

Biodesign Hernia Graft

Clinical Study ID

NCT04294446
19-004
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 HerniaGraft during their index procedure.

Study Design

Total Participants: 95
Treatment Group(s): 1
Primary Treatment: Biodesign Hernia Graft
Phase:
Study Start date:
November 10, 2020
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • St. Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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