Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323863
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-15
Brief Title:
Ultra-high Resolution CT the End of Stapes Prosthesis Measurement Misestimation
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Ultra-high Resolution CT the End of Stapes Prosthesis Measurement Misestimation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
Actual CT scanners overestimate stapes piston size and do not represent a valuable technique for their follow-up especially in case of complication Ultra-high resolution has not yet been evaluated in this setting
Detailed Description:
Modern temporal bone imaging systems using 05 mm slice thickness are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy as high-resolution CT measurements consistently overestimated intravestibular piston dimensions width by 44 length by 625 and vestibular intrusion by 39 because of metallic artifacts The exact limits of intravestibular depth are also unclear The safe intravestibular prosthesis depth varies widely between studies and has been reported to range from 02 to 25 mm so 39 may represent up to 09 mm of misestimation Ultra-high resolution CT UHR-CT has improved spatial resolution to 012 mm by using ultra-small detector elements 025 x 025 mm allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT HR-CT However this technique has not been described for stapes prosthesis measurement
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