Viewing Study NCT04489550



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Last Modification Date: 2024-10-26 @ 1:41 PM
Study NCT ID: NCT04489550
Status: COMPLETED
Last Update Posted: 2020-07-29
First Post: 2020-07-23

Brief Title: How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma
Sponsor: University Hospital Montpellier
Organization: University Hospital Montpellier

Study Overview

Official Title: Optimal Duration of Magnetic Resonance Imaging MRI Follow-up to Safely Identify Middle Ear Residual Cholesteatoma
Status: COMPLETED
Status Verified Date: 2020-07
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: None
Brief Summary: Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging non-EP DWI for residual cholesteatoma However limited data are available regarding a suitable length of imaging follow-up The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma
Detailed Description: A retrospective monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 15T MRI scanner MR images were reviewed independently by two radiologists Sensitivity and specificity values were calculated as a function of time after the surgery Receiver operating characteristics ROC curves were analyzed to determine the optimal follow-up duration

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None