Repairing eardrum perforations with a special graft
Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft
This study is testing a special graft to see if it can help close eardrum holes in patients who need it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 151 (estimated) |
| Sex | All |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 3 sites (Cincinnati, Ohio and 2 other locations) |
| Trial ID | NCT04635228 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients who receive the Cook® Biodesign® Otologic Repair Graft to close tympanic membrane perforations. Participants will be monitored for up to three months post-implantation to assess the success rate of complete closure of the eardrum. The study aims to gather data on the effectiveness of this graft in clinical settings. It focuses on patients who require tympanic membrane closure due to perforations.
Who should consider this trial
Good fit: Ideal candidates are patients needing closure of a tympanic membrane perforation.
Not a fit: Patients with a life expectancy of less than 12 months or known sensitivity to porcine material may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved healing outcomes for patients with eardrum perforations.
How similar studies have performed: Other studies on tympanic membrane repair have shown promising results, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient requires tympanic membrane closure. Exclusion Criteria: * Life expectancy \< 12 months * Known sensitivity to porcine material
Where this trial is running
Cincinnati, Ohio and 2 other locations
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals-Cleveland — Cleveland, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Noah Shields, MS
- Email: noah.shields@cookmedical.com
- Phone: 765 463 7537
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.