Intracochlear Potentials: Volta Study (CLTD5663)

January 27, 2025 updated by: Cochlear

Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • The Hearing Cooperative Research Centre
      • East Melbourne, Victoria, Australia, 30002
        • Royal Victorian Eye and Ear Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normative Voltage Tomography Data
Time Frame: intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.
Gather normative voltage tomography data for retrospective analysis. After insertion of the electrode array, TIM measurements will be taken from each subject using the cochlear implant system and Surgical Assistant Research Tool software. A Tip Foldover (TFO) in the software and x-rays will be used to identify any occurrence of a tip foldover.
intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital

Investigators

  • Principal Investigator: Robert Cowan, The HEARing CRC
  • Principal Investigator: Robert Briggs, The Royal Victorian Eye and Ear Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

October 10, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5663 (Other Identifier: Cochlear)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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