Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT03904316
Status:
WITHDRAWN
Last Update Posted:
2025-12-19
First Post:
2019-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Biodesign® Otologic Graft in Tympanoplasty
Sponsor:
Henry Ford Health System
Organization:
Study Overview
Official Title:
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped as the benefit was challenging to determine in preliminary usage.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.
Detailed Description:
Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: