Value of Trans-Impedance Matrix (TIM) measurement for detection of New Bone Formation (NBF) and influence on electrophysiology, residual hearing and performance.

Completed

• Conditions: New Bone Formation; severe-to-profound hearing loss; 10019243

• Registration Number: NL-OMON48046
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

All patients selected for cochlear implatation willing to participate (signed
informed consent for study protocol)

Exclusion Criteria

Patients unable to have a CT-scan
Patients with any anatomical situation influencing normal insertion

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Confirmation that NBF can reliably be detected using UHR CT-scan<br /><br>- Confirmation the TIM measurement is useful to detect and monitor NBF</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Investigate co-registered changes of C-/T-levels in relation with NBF growth<br /><br>- Confirm the influence of NBF on long term residual hearing<br /><br>- Investigate electrode position and correlate with study outcomes<br /><br>- Evaluate changes in performance over time possibly associated with NBF</p><br>