CLTD5663: Intracochlear Potentials: Volta Study

• Sponsor: Cochlear (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02852330
• Collaborator: The Hearing Cooperative Research Centre (Other), Royal Victoria Eye and Ear Hospital (Other)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site: 10
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• 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: Jul 10, 2017
• Actual Primary Completion Date: Oct 10, 2018
• Actual Study Completion Date: Oct 10, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Normative Voltage Tomography Data [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hearing Cooperative Research Centre	Carlton	Victoria	Australia	3053
2	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

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

Study Documents (Full-Text)

• Study Protocol - Feb 24, 2017
• Statistical Analysis Plan - Aug 7, 2019

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT02852330
• Other Study ID Numbers: CLTD5663; CLTD5663
• First Posted: Aug 2, 2016
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Hearing Loss

Study Results

Participant Flow

Arm/Group Title	Voltage Tomography
Arm/Group Description	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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Voltage Tomography
Arm/Group Description	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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively.
Overall Participants	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.3
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Australia	20 100%

Outcome Measures

1. Primary Outcome

Title	Normative Voltage Tomography Data
Description	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.
Time Frame	intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Voltage Tomography
Arm/Group Description	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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively.
Measure Participants	20
Nominal TIMs	19 95%
Anomalous TIMs	1 5%
Correct TIP detection	19 95%
Incorrect TIP detection	1 5%

Adverse Events

Time Frame	12 months
Arm/Group Title	Voltage Tomography
Arm/Group Description	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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively.
All Cause Mortality
	Voltage Tomography
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Voltage Tomography
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Cardiac disorders
Cardiac arrest	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Voltage Tomography
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.