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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign Otologic Repair Graft | Device | The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of closure | Percent of patients with complete closure of the tympanic membrane. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Any eligible patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health | Indianapolis | Indiana | 46202 | United States | ||
| Cincinnati Children's Hospital |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| Cincinnati |
| Ohio |
| 45229 |
| United States |
| University Hospitals-Cleveland | Cleveland | Ohio | 44106 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Gloucestershire Royal Hospital | Gloucester | GL 3NN | United Kingdom |