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.
Study Type
OBSERVATIONAL
Enrollment
87
The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure.
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
Percent of closure
Percent of patients with complete closure of the tympanic membrane.
Time frame: 3 months
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Gloucestershire Royal Hospital
Gloucester, United Kingdom