Biodesign® Otologic Repair Graft

NCT ID: NCT04635228

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-29

Study Completion Date

2025-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Tympanic Membrane Perforation Eardrum Perforation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biodesign Otologic Repair Graft

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient requires tympanic membrane closure.

Exclusion Criteria

* Life expectancy \< 12 months
* Known sensitivity to porcine material
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IU Health

Indianapolis, Indiana, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

University Hospitals-Cleveland

Cleveland, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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17-08

Identifier Type: -

Identifier Source: org_study_id

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