Status:
RECRUITING
Post-market Study of the Biodesign Hernia Graft
Lead Sponsor:
Cook Biotech Incorporated
Conditions:
Ventral Hernia
Eligibility:
All Genders
18+ years
Brief 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 wil...
Eligibility Criteria
Inclusion
- 1\. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft
Exclusion
- Known sensitivity to porcine material
- For the study, the following patients will also be excluded:
- Age \< 18 years
- Unable or unwilling to provide informed consent
- Life expectancy of less than one year from the date of the index procedure
- Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.
Key Trial Info
Start Date :
November 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04294446
Start Date
November 10 2020
End Date
June 30 2027
Last Update
December 17 2024
Active Locations (3)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9