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NCT04635228 Clinical Trial

Biodesign® Otologic Repair Graft

Tympanic Membrane Perforation Clinical Trial

Official title:
Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04635228
Other study ID # 17-08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2021
Est. completion date March 2026

Study information
Verified date December 2023
Source Cook Group Incorporated
Contact Noah Shields, MS
Phone 765 463 7537
Email noah.shields@cookmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.

Recruitment information / eligibility
Status Recruiting
Enrollment 151
Est. completion date March 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient requires tympanic membrane closure. Exclusion Criteria: - Life expectancy < 12 months - Known sensitivity to porcine material

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Biodesign Otologic Repair Graft
The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure.

Locations
Country Name City State
United States Cincinnati Children's Hospital Cincinnati Ohio
United States University Hospitals-Cleveland Cleveland Ohio
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of closure Percent of patients with complete closure of the tympanic membrane. 3 months
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