Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT02901093
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Prosthesis Penetration With Conebeam in Otosclerosis
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Study Overview
Official Title:
Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUIPROCOS
Brief Summary:
Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.
Unfortunately, there is very little data in an unselected series of uneventful patients.
The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).
Unfortunately, there is very little data in an unselected series of uneventful patients.
The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: