Trial Outcomes & Findings for Implantation With the Nucleus CI532 Cochlear Implant in Adults (NCT NCT02677220)
NCT ID: NCT02677220
Last Updated: 2019-03-12
Results Overview
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.
TERMINATED
NA
1 participants
3 months post-activation
2019-03-12
Participant Flow
Participant milestones
| Measure |
Surgical
Subjects implanted with the CI532 cochlear implant in one ear
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Surgical
Subjects implanted with the CI532 cochlear implant in one ear
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Surgical
n=1 Participants
Subjects implanted with the CI532 cochlear implant in one ear
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 0 • n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 3 months post-activationThe AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.
Outcome measures
| Measure |
Surgical
n=1 Participants
Subjects implanted with the CI532 cochlear implant in one ear
|
|---|---|
|
AzBio Sentence Recognition in Noise
|
35 percent correct
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 months post-activationPopulation: subject did not reach endpoint - GBI was not collected at 3 months per protocol
The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-activationPopulation: subject did not reach endpoint - SSQ was not collected at 3 months per protocol
The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).
Outcome measures
Outcome data not reported
Adverse Events
Surgical
Serious adverse events
| Measure |
Surgical
n=1 participants at risk
Subjects with the CI532 cochlear implant in one ear
|
|---|---|
|
Ear and labyrinth disorders
Device Explant
|
100.0%
1/1 • 8 months
SAE October 2016 - blood and pus draining from the incision. Antibiotics prescribed. November 2016 - resolved. Initial activation of the device. December 2016 through April 26, 2017 - continued drainage and treatment using a combination of routine wound care and oral antibiotics. June 2017 - Explantation required July 2017 - Withdrawn - test device was no longer in place.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place