Skip to main content
OpenTrials
Completed

NCT Number: NCT02852330

Intracochlear Potentials: Volta Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hearing Cooperative Research Centre, Carlton, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Recipient of a Nucleus 24 ABI device
  • Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
  • 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.
  • Unwillingness or inability of the candidate to comply with all investigational requirements.

Treatment and study plan

SA16 research software

Device

Software for measurement of voltage tomography intraoperatively.

CS19 (1.6.2)

Device

Software for measurement of voltage tomography post-operatively.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Royal Victoria Eye and Ear Hospital
  • The Hearing Cooperative Research Centre

Registry information

Official study title

Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation

Acronym: CLTD5663

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2016
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.