Biodesign® Otologic Repair Graft

Recruiting

• Conditions: Eardrum Perforation; Tympanic Membrane Perforation

• Registration Number: NCT04635228
• Lead Sponsor: Cook Research Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Study Start: 2021-09-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Patient requires tympanic membrane closure.

Exclusion Criteria

• Life expectancy < 12 months
• Known sensitivity to porcine material

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of closure	3 months	Percent of patients with complete closure of the tympanic membrane.

Trial Locations

Locations (3)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

University Hospitals-Cleveland; 🇺🇸 Cleveland, Ohio, United States