Biodesign® Otologic Repair Graft

Cook Group

Status: Completed

Conditions: Eardrum Perforation; Tympanic Membrane Perforation

Treatments: Device: Biodesign Otologic Repair Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT04635228

17-08

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requires tympanic membrane closure.

Exclusion criteria

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