Biodesign® Otologic Repair Graft

Last updated: July 7, 2025
Sponsor: Cook Research Incorporated
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Ear Infections (Pediatric)

Otitis Media

Treatment

Biodesign Otologic Repair Graft

Clinical Study ID

NCT04635228
17-08
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient requires tympanic membrane closure.

Exclusion

Exclusion Criteria:

  • Life expectancy < 12 months

  • Known sensitivity to porcine material

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Biodesign Otologic Repair Graft
Phase:
Study Start date:
September 29, 2021
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Policlinico di Modena (University Hospital of Modena)

    Modena, 41124
    Italy

    Site Not Available

  • Inselpital Bern (University Hospital of Bern)

    Bern, 8 3010
    Switzerland

    Site Not Available

  • Gloucestershire Royal Hospital

    Gloucester, GL 3NN
    United Kingdom

    Site Not Available

  • IU Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • UMASS Memorial Medical Center

    Worcester, Massachusetts 05116
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University Hospitals-Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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