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Intracochlear Potentials: Volta Study (CLTD5663)

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ClinicalTrials.gov Identifier: NCT02852330
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
Information provided by (Responsible Party):
Cochlear

Brief Summary:
Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months post-activation with CS19 research software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: SA16 research software Device: CS19 (1.6.2) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet current cochlear implant indications at the implanting centre for a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant
  2. Aged 18 years and older at the time of implantation.

Exclusion Criteria:

  1. Recipient of a Nucleus 24 ABI device
  2. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
  3. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
  4. Unwillingness or inability of the candidate to comply with all investigational requirements.

Information from the National Library of Medicine

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


Locations
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Australia, Victoria
The Hearing Cooperative Research Centre
Carlton, Victoria, Australia, 3053
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, 30002
Sponsors and Collaborators
Cochlear
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
Investigators
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Principal Investigator: Robert Cowan The HEARing CRC
Principal Investigator: Robert Briggs The Royal Victorian Eye and Ear Hospital
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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02852330    
Other Study ID Numbers: CLTD5663
CLTD5663 ( Other Identifier: Cochlear )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cochlear:
Voltage tomography
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases