NCT04635228

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

November 13, 2020

Last Update Submit

January 5, 2026

Conditions

Tympanic Membrane PerforationEardrum Perforation

Keywords

tympanoplastymyringoplasty

Outcome Measures

Primary Outcomes (1)

  • Percent of closure

    Percent of patients with complete closure of the tympanic membrane.

    3 months

Interventions

Biodesign Otologic Repair GraftDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any eligible patient

You may qualify if:

  • Patient requires tympanic membrane closure.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

IU Health

Indianapolis, Indiana, 46202, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

University Hospitals-Cleveland

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Gloucestershire Royal Hospital

Gloucester, GL 3NN, United Kingdom

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

September 29, 2021

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(4)GB(1)