Intracochlear Potentials: Volta Study (CLTD5663)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02852330|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Device: SA16 research software Device: CS19 (1.6.2)||Not Applicable|
The clinical investigation will gather impedance and transimpedance (voltage tomography) data intraoperatively and post-operatively which can be used to characterize the electrical properties of the living cochlea.
The Surgical Assistant Research Tool (SA16) research software is a software tool developed by Cochlear Limited. The use of the SA16 research software in the current clinical investigation is intended to support Cochlear's research into the development of implant telemetry based surgical tools.
The SA16 research software is designed to perform a series of predefined measurements with minimal intervention both during and immediately following electrode insertion using telemetry from the implant via the Sound Processor to the computer. These measurements include real time continuous measurements, intended for use during the electrode insertion portion of the surgical procedure, and baseline measurements following the completion of electrode insertion.
The SA16 research software will be used in the current clinical investigation in adults who meet current indications for cochlear implantation in Australia. The SA16 research software is not for use with patients who are receiving an implant that directly contacts neural tissue, such as auditory brainstem implants (ABI).
CS19 (1.6.2) software will be used to collect voltage tomography measurements post-implantation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation|
|Actual Study Start Date :||July 10, 2017|
|Actual Primary Completion Date :||October 10, 2018|
|Actual Study Completion Date :||October 10, 2018|
Experimental: Voltage tomography
Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.
Device: SA16 research software
Software for measurement of voltage tomography intraoperatively.
Device: CS19 (1.6.2)
Software for measurement of voltage tomography post-operatively.
- Voltage tomography data measurement [ Time Frame: intraoperatively ]normative voltage tomography data measurement during and/or immediately after electrode insertion into the cochlea using Surgical Assistant Research Tool (SA16) software
- Voltage tomography data measurement [ Time Frame: post-operatively at device activation (1 month post surgery), 3 months post-activation and 12 months post-activation ]normative voltage tomography data measurement at activation (1 month post-surgery), 3 months post-activation and 12 months post-activation using CS19 (1.6.2) software.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852330
|The Hearing Cooperative Research Centre|
|Carlton, Victoria, Australia, 3053|
|Royal Victorian Eye and Ear Hospital|
|East Melbourne, Victoria, Australia, 30002|
|Principal Investigator:||Robert Cowan||The HEARing CRC|
|Principal Investigator:||Robert Briggs||The Royal Victorian Eye and Ear Hospital|