Trial Outcomes & Findings for Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms (NCT NCT03294681)

Results Overview

Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.

Recruitment status

COMPLETED

Target enrollment

153 participants

Primary outcome timeframe

at surgery, within one minute

Results posted on

2020-06-29

Participant Flow

153 participants were recruited in six centres from 03 October 2017 to 29 May 2019.

Participant milestones

Participant milestones
Measure	Cochlear Implant Recipients CI532 and CI512 cochlear implant recipients
Overall Study STARTED	153
Overall Study COMPLETED	152
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cochlear Implant Recipients CI532 and CI512 cochlear implant recipients
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cochlear Implant Recipients n=152 Participants CI532 and CI512 cochlear implant recipients
Age, Continuous	58 years n=152 Participants
Sex: Female, Male Female	79 Participants n=152 Participants
Sex: Female, Male Male	73 Participants n=152 Participants
Region of Enrollment Australia	9 Participants n=152 Participants
Region of Enrollment Germany	115 Participants n=152 Participants
Region of Enrollment Spain	28 Participants n=152 Participants

PRIMARY outcome

Timeframe: at surgery, within one minute

Population: 148 ears were analyzed from 145 participants (with three bilateral participants providing 148 ears). From the 152 baseline participants, seven were excluded from the analysis: for three participants, no transimpedance data were obtained intra-operatively and for four participants the transimpedance data showed measurement abnormalities.

Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.

Outcome measures

Outcome measures
Measure	Cochlear Implant Recipients n=148 ears CI532 and CI512 cochlear implant recipients
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over	98.6 Percentage of ears Interval 95.8 to 99.75

Adverse Events

Cochlear Implant Recipients

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cochlear Implant Recipients n=153 participants at risk CI532 and CI512 cochlear implant recipients
Renal and urinary disorders Renal carcinoma	0.65% 1/153 • Number of events 1 • 3 months
General disorders Pass out related to heat	0.65% 1/153 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Nicole Neben

Cochlear

Phone: +4951154277220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators can publish and/or present their own data and process their data with their own algorithms. At study end 2 joint publications by the clinical investigators/sponsor are planned with the Coordinating Investigator writing the publication. All abstract/publication must be reviewed by the sponsor at least 30 days in advance. If a publication contains information that the sponsor finds worth protecting the sponsor has the right to delay the publication/presentation for 90 days.
Publication restrictions are in place

Restriction type: OTHER