CHANGE Feasibility Study (CLTD5626)
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|ClinicalTrials.gov Identifier: NCT02671032|
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Device: Nucleus CI532 cochlear implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.|
|Actual Study Start Date :||January 5, 2016|
|Actual Primary Completion Date :||July 15, 2019|
|Actual Study Completion Date :||July 15, 2019|
Experimental: Implantation with Nucleus CI532 cochlear implant
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Device: Nucleus CI532 cochlear implant
- Report on degree of hearing as measured by pure tone audiogram [ Time Frame: 6 months post activation ]unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
- Report on clinical performance in quiet and noise [ Time Frame: 6 months post activation ]speech perception assessment with monosyllabic words and sentences in competing noise at a fixed signal-to-noise ratio (+5dB).
- Report of medical/surgical and device related adverse events. [ Time Frame: 12 months post activation. ]Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
- Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing scale (SSQ) [ Time Frame: 6 months post activation ]Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation.
- Glasgow Benefit Inventory (GBI). [ Time Frame: 6 months post activation ]Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671032
|The Hearing Cooperative Research Centre|
|Carlton, Victoria, Australia, 3053|
|Royal Victorian Eye and Ear Hospital|
|East Melbourne, Victoria, Australia, 30002|
|Principal Investigator:||Robert Cowan, DipAud PhD||HEARing CRC|