Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2023-10-25
2024-10-01
Brief Summary
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This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software.
Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cochlear implant electrode insertion depth estimation
Electrode insertion depth estimation using impedance telemetry data measured during cochlear implantation and at three regular follow-up visits
STOP
Software to measure impedance telemetry data
MAESTRO
Software to measure impedance telemetry data
Interventions
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STOP
Software to measure impedance telemetry data
MAESTRO
Software to measure impedance telemetry data
Eligibility Criteria
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Inclusion Criteria
* Subjects scheduled for CI surgery according to clinical routine
* Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
* No radiological contraindications
* Stated willingness to comply with all study procedures for the duration of the study
* Subjects incapable of giving informed consent
* Age under 18 years
* Pregnancy
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Marco Caversaccio, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
Locations
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Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
Bern, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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PATHOS
Identifier Type: -
Identifier Source: org_study_id
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