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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48046

Enrollment

Registered

2019-08-27

Start date

2019-11-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New Bone Formation severe-to-profound hearing loss

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- Confirmation that NBF can reliably be detected using UHR CT-scan - Confirmation the TIM measurement is useful to detect and monitor NBF	—

Secondary

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

Countries

Netherlands

Outcome results