Biodesign® Otologic Repair Graft

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04635228

Enrollment

Registered

2020-11-19

Start date

2021-09-29

Completion date

2025-12-23

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eardrum Perforation, Tympanic Membrane Perforation

Keywords

tympanoplasty, myringoplasty

Brief 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.

Interventions

DEVICEBiodesign Otologic Repair Graft

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient requires tympanic membrane closure.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Percent of closure	3 months	Percent of patients with complete closure of the tympanic membrane.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026