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| Name | Class |
|---|---|
| The Hearing Cooperative Research Centre | OTHER |
| Royal Victoria Eye and Ear Hospital | OTHER_GOV |
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The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation with Nucleus CI532 cochlear implant | Experimental | All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus CI532 cochlear implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Report on Degree of Hearing as Measured by Pure Tone Audiogram | unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear. | 6 months and 12 months post activation |
| Report on Clinical Performance in Quiet and Noise | Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB). | 3 months, 6 months and 12 months post activation |
| Report of Medical/Surgical and Device Related Adverse Events. | Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness. | 12 months post activation. |
| Measure | Description | Time Frame |
|---|---|---|
| Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions. | Preoperative and 6 months post activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cowan, DipAud PhD | HEARing CRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hearing Cooperative Research Centre | Carlton | Victoria | 3053 | Australia | ||
| Royal Victorian Eye and Ear Hospital |
Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Implantation With Nucleus CI532 Cochlear Implant | All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. Nucleus CI532 cochlear implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implantation With Nucleus CI532 Cochlear Implant | All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. Nucleus CI532 cochlear implant |
| 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 | Report on Degree of Hearing as Measured by Pure Tone Audiogram | unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear. | Posted | Number | participants | 6 months and 12 months post activation |
|
|
12 months and 30 days
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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 | Implantation With Nucleus CI532 Cochlear Implant | All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. Nucleus CI532 cochlear implant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort/Pain of Pinna and Behind | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernadette Pickering | Cochlear | +61296115909 | bpickering@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2017 | Sep 4, 2020 | Prot_SAP_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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| Glasgow Benefit Inventory (GBI). | Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome. | 6 months post activation |
| East Melbourne |
| Victoria |
| 30002 |
| Australia |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Average Initial Age of Hearing Aid Fitted | Mean | Full Range | years |
|
| Onset of Initial Hearing Loss | Mean | Full Range | years |
|
| Severe Hearing Loss | Severe hearing loss is classified as hearing loss of 66-90 dB | Count of Participants | Participants |
|
|
| Primary | Report on Clinical Performance in Quiet and Noise | Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB). | Posted | Mean | Standard Deviation | percentage of correct words | 3 months, 6 months and 12 months post activation |
|
|
|
| Primary | Report of Medical/Surgical and Device Related Adverse Events. | Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness. | Posted | Number | Adverse Events | 12 months post activation. |
|
|
|
| Secondary | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions. | Posted | Mean | Standard Deviation | score on a scale | Preoperative and 6 months post activation |
|
|
|
| Secondary | Glasgow Benefit Inventory (GBI). | Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome. | Posted | Mean | Full Range | score on a scale | 6 months post activation |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| Onset of tinnitus in right ear | Injury, poisoning and procedural complications | Non-systematic Assessment | Possibly related to procedure |
|
| Dizziness | Injury, poisoning and procedural complications | Non-systematic Assessment | Two events possibly related to procedure and/or device |
|
| Drop in hearing | Injury, poisoning and procedural complications | Non-systematic Assessment | Possibly related to procedure and/or device |
|
| Nausea | Injury, poisoning and procedural complications | Non-systematic Assessment | Possibly related to procedure and/or device |
|
| Cold-like symptoms including sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Headache | Injury, poisoning and procedural complications | Non-systematic Assessment | One event possibly related to procedure |
|
| Jaw ache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Incision site tenderness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Otitis Externa | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Vomiting | Nervous system disorders | Non-systematic Assessment |
|
| Abscess in left breast | Infections and infestations | Non-systematic Assessment |
|
| Polymyalgia Rheumatica | Immune system disorders | Non-systematic Assessment |
|
| Arm infection | Infections and infestations | Non-systematic Assessment |
|
| Cactus injury to wrist | Injury, poisoning and procedural complications | Non-systematic Assessment | Not related to procedure |
|
| Hip pain left and right sides | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in body joints | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sun spot removal (actinic keratosis) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Quiet, electronic alone 6 months |
|
| Quiet, electronic alone 12 months |
|
| Quiet, hybrid hearing 3 months |
|
| Quiet, hybrid hearing 6 months |
|
| Quiet, hybrid hearing 12 months |
|
| Noise baseline, untreated ear |
|
| Noise baseline, treated ear |
|
| Noise, electric alone 3 months |
|
| Noise, electric alone 6 months |
|
| Noise, electric alone 12 months |
|
| Noise, hydrid hearing 3 months |
|
| Noise, hybrid hearing 6 months |
|
| Noise, hybrid hearing 12 months |
|
| Title | Measurements |
|---|
|
| Possibly procedure related - nausea |
|
| Possibly procedure related - right ear tinnitus |
|
| Procedure related - headache |
|
| Procedure related - incision site pain |
|
| Procedure related - incision site tenderness |
|
| Procedure related - jaw ache |
|
| Procedure related - initial insertion tip foldover |
|
| Possibly device related - pinna/behind pain |
|
| Possibly device related - dizziness |
|
| Possibly device related - drop in hearing |
|
| Possibly device related - nausea |
|
| Device related - initial insertion top foldover |
|
| Title | Measurements |
|---|---|
|
| Baseline - Overall SSQ |
|
| 6 Month - Speech Hearing |
|
| 6 Month - Spatial Hearing |
|
| 6 Month - Qualities of Hearing |
|
| 6 Month - Overall SSQ |
|
| Title | Measurements |
|---|---|
|
| Average Benefit |
|