Clinical trial NCT02852330: Intracochlear Potentials: Volta Study
Official title: Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Voltage tomography
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: The Hearing Cooperative Research Centre
name: Royal Victoria Eye and Ear Hospital
First posted: 2016-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Normative Voltage Tomography Data
timeFrame: intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: The Hearing Cooperative Research Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
Study officials:
affiliation: The HEARing CRC
name: Robert Cowan
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Victorian Eye and Ear Hospital
name: Robert Briggs
role: PRINCIPAL_INVESTIGATOR
References: