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Biodesign® Otologic Repair Graft

NCT04635228 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2026-01-07

No results posted yet for this 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.

Conditions

  • Tympanic Membrane Perforation
  • Eardrum Perforation

Interventions

DEVICE

Biodesign Otologic Repair Graft

The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure.

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2025-12-23
Completion
2025-12-23

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635228 on ClinicalTrials.gov