Trial Outcomes & Findings for Intracochlear Potentials: Volta Study (NCT NCT02852330)
NCT ID: NCT02852330
Last Updated: 2025-02-10
Results Overview
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.
COMPLETED
NA
20 participants
intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.
2025-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Voltage Tomography
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
70.3 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Voltage Tomography
n=20 Participants
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.
|
|---|---|
|
Normative Voltage Tomography Data
Nominal TIMs
|
19 Participants
|
|
Normative Voltage Tomography Data
Anomalous TIMs
|
1 Participants
|
|
Normative Voltage Tomography Data
Correct TIP detection
|
19 Participants
|
|
Normative Voltage Tomography Data
Incorrect TIP detection
|
1 Participants
|
Adverse Events
Voltage Tomography
Serious adverse events
| Measure |
Voltage Tomography
n=20 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place