Post-market real-world data collection of the Biodesign® Otologic Repair Graft.
C
Charles Yates, MD
Primary Investigator
Overview
The primary objective of this clinical study is to collect additional safety and performance data through 3-months post-operative follow-up period on the Biodesign® Otologic Repair Graft in clinical use.
Description
This study is intended to confirm the continued safety and performance of the Biodesign
Otologic Repair Graft throughout the expected lifetime of the device (6-12 weeks), particularly
in respect to the identified risks and side-effects associated with its use; to identify and analyze
emergent risks and previously unknown side-effects; and to ensure continued acceptability of the
benefit-risk ratio.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Otological repair
-
Age: - 100 Years
-
Gender: All
Inclusion Criteria:
- A patient is suitable for inclusion in the clinical study if the patient requires a tympanic membrane closure procedure with planned use of the Biodesign Otologic Repair Graft in accordance with the IFU.
Exclusion Criteria:
- 1. Unable or unwilling to provide written informed consent and/or assent (in case of pediatric patients)
- 2. Life expectancy < 12 months
- 3. Known sensitivity to porcine material
Updated on
07 May 2024.
Study ID: 18143; OTHN-COOK-17-08
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