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OpenTrials
Completed

NCT Number: NCT04635228

Biodesign® Otologic Repair Graft

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.

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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Eardrum Perforation Otorhinolaryngologic Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Gloucestershire Royal Hospital, Gloucester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient requires tympanic membrane closure.

Exclusion criteria

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

Treatment and study plan

Biodesign Otologic Repair Graft

Device

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

Primary outcomes

  1. Percent of closure

    Time frame: 3 months

    Percent of patients with complete closure of the tympanic membrane.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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