Biodesign® Otologic Repair Graft

Description

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.

Conditions

Tympanic Membrane Perforation, Eardrum Perforation

Study Overview

Study Details

Study overview

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.

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

Biodesign® Otologic Repair Graft

Condition
Tympanic Membrane Perforation
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229

Cleveland

University Hospitals-Cleveland, Cleveland, Ohio, United States, 44106

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient requires tympanic membrane closure.
  • * Life expectancy \< 12 months
  • * Known sensitivity to porcine material

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cook Research Incorporated,

Study Record Dates

2026-03