Evaluating the Biodesign Hernia Graft for ventral hernia repair
Post-market Study of the Biodesign® Hernia Graft
This study is testing how well the Biodesign Hernia Graft works for repairing ventral hernias in a diverse group of patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cook Biotech Incorporated Industry-sponsored |
| Locations | 3 sites (Nashville, Tennessee and 2 other locations) |
| Trial ID | NCT04294446 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the performance of the Biodesign® Hernia Graft used in surgical repairs of ventral hernias. It will enroll up to 95 patients across 10 clinical sites, ensuring a diverse representation of patients and surgical techniques. The study is designed to gather real-world data on the effectiveness of the graft in reinforcing soft tissues during hernia repair procedures. Inclusion and exclusion criteria are based on the device's instructions for use to ensure relevant outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with primary or recurrent ventral hernias requiring surgical repair using a Biodesign Hernia Graft.
Not a fit: Patients with known sensitivity to porcine material or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Biodesign Hernia Graft, potentially improving surgical outcomes for patients with ventral hernias.
How similar studies have performed: While this study focuses on a specific product, similar approaches in evaluating hernia grafts have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee and 2 other locations
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Queen Elizabeth II Hospital — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Carina Gregory, MS
- Email: cgregory@rtix.com
- Phone: 765-497-3385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.