Post-market Study of the Biodesign Hernia Graft

Launched by COOK BIOTECH INCORPORATED · Mar 3, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at the Biodesign® Hernia Graft, which is a medical device used to help repair ventral hernias. A ventral hernia occurs when tissue pushes through a weak spot in the abdominal muscles, and this graft is designed to reinforce the tissue during surgery. The goal of the study is to gather information about how well this graft works in patients who need surgery for either a new or recurring hernia.

To be part of the study, participants must be between the ages of 18 and 74 and need surgery for a ventral hernia that requires the use of the Biodesign Hernia Graft. However, individuals with a known sensitivity to pig-based materials or those with serious health issues that could affect their recovery may not be eligible. If you join the study, you can expect to have your surgery as planned, and researchers will follow your progress to see how well the graft performs. This study is important because it helps ensure that the graft is safe and effective for patients needing hernia repair.

Gender

ALL

Eligibility criteria

• 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.