Biodesign® Otologic Repair Graft

Completed

Conditions studied: Tympanic Membrane Perforation, Eardrum Perforation

In brief

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.

Key facts

Study ID

NCT04635228

Run by

Cook Research Incorporated

People needed

87

Starts

2021-09-29

Expected to finish

2025-12-23

Last updated by the study team

2026-01-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient requires tympanic membrane closure.

You may not qualify if…

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

Where it is running

• IU Health — Indianapolis, Indiana, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University Hospitals-Cleveland — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Gloucestershire Royal Hospital — Gloucester, United Kingdom

Full record on ClinicalTrials.gov

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