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Search / Trial NCT04635228

Biodesign® Otologic Repair Graft

Launched by COOK RESEARCH INCORPORATED · Nov 13, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Tympanoplasty Myringoplasty

ClinConnect Summary

This clinical trial is studying a special graft called the Cook® Biodesign® Otologic Repair Graft, which is designed to help close holes in the eardrum, known as tympanic membrane perforations. The goal is to see how many patients have complete healing of their eardrum within three months after receiving the graft.

To be eligible for this trial, you need to have a perforated eardrum that requires treatment. It’s important to note that people with a life expectancy of less than 12 months or those who are allergic to pig-derived materials cannot participate. If you join the study, you can expect to have regular check-ups to monitor your healing over the three-month period. This trial is currently looking for participants of all ages and genders, so if you or a loved one may benefit, it could be a great opportunity to help improve treatment options for eardrum repair.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient requires tympanic membrane closure.
  • Exclusion Criteria:
  • Life expectancy \< 12 months
  • Known sensitivity to porcine material

About Cook Research Incorporated

Cook Research Incorporated is a leading clinical trial sponsor dedicated to advancing medical innovation through rigorous research and development. With a strong commitment to improving patient outcomes, Cook Research specializes in the design and execution of clinical studies across various therapeutic areas. The organization leverages its extensive experience and expertise to collaborate with healthcare professionals, regulatory bodies, and industry partners, ensuring adherence to the highest standards of safety and compliance. By fostering a culture of integrity and scientific excellence, Cook Research is at the forefront of delivering impactful solutions to complex medical challenges.

Locations

Philadelphia, Pennsylvania, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Cleveland, Ohio, United States

Modena, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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