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| ID | Type | Description | Link |
|---|---|---|---|
| CLTD5663 | Other Identifier | Cochlear |
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| Name | Class |
|---|---|
| The Hearing Cooperative Research Centre | OTHER |
| Royal Victoria Eye and Ear Hospital | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voltage tomography | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA16 research software | Device | Software for measurement of voltage tomography intraoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normative Voltage Tomography Data | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cowan | The HEARing CRC | Principal Investigator |
| Robert Briggs | The Royal Victorian Eye and Ear Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hearing Cooperative Research Centre | Carlton | Victoria | 3053 | Australia | ||
| Royal Victorian Eye and Ear Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Normative Voltage Tomography Data | 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. | Posted | Count of Participants | Participants | intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes. |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. SA16 research software: Software for measurement of voltage tomography intraoperatively. CS19 (1.6.2): Software for measurement of voltage tomography post-operatively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment | Cardiac arrest during hip replacement surgery, resulting in cochlear implant surgery cancellation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernadette Pickering | Cochlear | +61296115909 | bpickering@cochlear.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2016 | Jan 27, 2025 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| CS19 (1.6.2) | Device | Software for measurement of voltage tomography post-operatively. |
|
| East Melbourne |
| Victoria |
| 30002 |
| Australia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |