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UnknownNCT06323863

Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation

Status
Unknown
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 0.5 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 6.25%) 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 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREstapedectomystapes removal and replacement by a prosthesis
RADIATIONultra high resolution CTimaging study

Timeline

Start date
2024-04-01
Primary completion
2024-06-01
Completion
2024-12-01
First posted
2024-03-21
Last updated
2024-03-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06323863. Inclusion in this directory is not an endorsement.

Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation (NCT06323863) · Clinical Trials Directory