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No enrolled subjects
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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
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The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.
The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Experimental | Subjects to be implanted with the CI532 cochlear implant in one ear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI532 cochlear implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| AzBio Sentence Recognition in Noise | 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. | 3 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Benefit Inventory | 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. | 6 months post-activation |
| Speech, Spatial, and Qualities of Hearing Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical | Subjects implanted with the CI532 cochlear implant in one ear |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical | Subjects implanted with the CI532 cochlear implant in one ear |
| 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 | AzBio Sentence Recognition in Noise | 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. | Posted | Mean | Standard Deviation | percent correct | 3 months post-activation |
|
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.
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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 | Surgical | Subjects with the CI532 cochlear implant in one ear | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Explant | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Cochlear | 3032647180 | loneill@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 | Apr 16, 2016 | Jan 30, 2019 | Prot_000.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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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). |
| 6 months post-activation |
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Glasgow Benefit Inventory | 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. | subject did not reach endpoint - GBI was not collected at 3 months per protocol | Posted | 6 months post-activation |
|
|
| Secondary | Speech, Spatial, and Qualities of Hearing Scale | 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). | subject did not reach endpoint - SSQ was not collected at 3 months per protocol | Posted | 6 months post-activation |
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|
| 1 |
| 1 |
| 1 |
| 0 |
| 1 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |