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Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus CI422 Cochlear Implant with N6 Sound Processor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test | Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score) | Preoperative baseline to 6 months postactivation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States | ||
| University of North Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nucleus CI422 Cochlear Implant With N6 Sound Processor | Newly implanted patient population seeking cochlear implantation as standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nucleus CI422 Cochlear Implant With N6 Sound Processor | Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test | Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score) | Posted | Mean | Standard Deviation | percentage correct | Preoperative baseline to 6 months postactivation |
|
|
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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 | Nucleus CI422 Cochlear Implant With N6 Sound Processor | Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irregular heartbeat | Cardiac disorders | Systematic Assessment | Admitted overnight for irregular heartbeat |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New or worsened tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Cochlear Americas | 303-264-2340 | knix@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2014 | Dec 21, 2018 | SAP_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 1, 2014 | Mar 22, 2019 | Prot_ICF_001.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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| Chapel Hill |
| North Carolina |
| 27517 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
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| Region of Enrollment | Number | participants |
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| 0 |
| 55 |
| 5 |
| 55 |
| 34 |
| 55 |
|
| Broken hip | Musculoskeletal and connective tissue disorders |
|
| Vertigo or dizziness | Ear and labyrinth disorders | Vertigo started 1 day post-op after discharged from surgery. Admitted for observation and provided steroids. |
|
| Atrial fibrillation | Cardiac disorders | Admitted to hospital for atrial fibrillation. Discharged without further episodes. |
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| Revision surgery | Ear and labyrinth disorders |
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| Vertigo or dizziness | Ear and labyrinth disorders |
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| Skin flap | Ear and labyrinth disorders |
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| Device related/programming problems | Ear and labyrinth disorders |
|
| Hearing loss | Ear and labyrinth disorders |
|
| Earmold or acoustic component sores | Ear and labyrinth disorders |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |