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| Name | Class |
|---|---|
| NAMSA | OTHER |
| Avania | INDUSTRY |
| Vanderbilt University | OTHER |
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An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | Experimental |
| |
| CI632 Comparator Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI632D | Device | CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative | The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion. | Six months postoperative |
| Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D | Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only. | Six months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Adverse events were recorded from baseline to 12 months postoperative. | Twelve months postoperative |
| Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Parkinson | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Centre | Englewood | Colorado | 80113 | United States | ||
| University of Iowa |
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| ID | Title | Description |
|---|---|---|
| FG000 | CI632D Investigational Medical Device (IMD) | CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) |
| FG001 | CI632 Comparator Device | CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | CI632D Investigational Medical Device (IMD) | CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) |
| BG001 | CI632 Comparator Device |
| 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 | Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative | The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion. | All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12. | Posted | Mean | Standard Deviation | kOhms | Six months postoperative |
|
Baseline to 12 months postoperative
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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 | CI632D Investigational Medical Device (IMD) | CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reimplantation due to electrode tip fold over | Surgical and medical procedures | Non-systematic Assessment | The event was classified as serious because rehospitalization was required to replace the implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
Early study termination leading to small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Parkinson | Cochlear | 13039414951 | aparkinson@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 | Nov 7, 2022 | Apr 2, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| CI632 | Device | CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone |
|
Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. |
| Six months postoperative |
| Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative | Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. | Six months postoperative |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| New York Eye & Ear infirmary of Mt. Sinai | New York | New York | 10010 | United States |
| NYU Langone Medical Center | New York | New York | 10017 | United States |
| Fiona Stanley Hospital | Murdoch | New South Wales | 6150 | Australia |
| Westmead Hospital | Sydney | New South Wales | 2145 | Australia |
| Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| Gilles Hospital | Auckland | 1010 | New Zealand |
| Protocol Violation |
|
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CI632 Comparator Device | CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone |
|
|
| Primary | Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D | Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only. | All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12. | Posted | Mean | Standard Deviation | percentage points | Six months postoperative |
|
|
|
| Secondary | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Adverse events were recorded from baseline to 12 months postoperative. | Intent-to-treat group at 12 months. This is the number of participants who were randomized. | Posted | Count of Participants | Participants | No | Twelve months postoperative |
|
|
|
| Secondary | Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative | Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. | All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12. | Posted | Mean | Standard Deviation | percentage points | Six months postoperative |
|
|
|
| Secondary | Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative | Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. | All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12. | Posted | Mean | Standard Deviation | percentage correct | Six months postoperative |
|
|
|
| 0 |
| 14 |
| 3 |
| 14 |
| 9 |
| 14 |
| EG001 | CI632 Comparator Arm | Standard CI632 device | 0 | 15 | 2 | 15 | 10 | 15 |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Discomfort | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Hypertension | General disorders | Non-systematic Assessment |
|
| Wound dehiscence | General disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Bruise | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non malignant neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Balance problems | Nervous system disorders | Non-systematic Assessment |
|
| Cognitive changes | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Numbness | Nervous system disorders | Non-systematic Assessment |
|
| Undesired nerve stimulation | Nervous system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin inflammation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Implant pain | Surgical and medical procedures | Non-systematic Assessment |
|
| Inadequate pain relief | Surgical and medical procedures | Non-systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| One or more related (possibly, probably, definitely) AEs |
|
| Procedure related |
|
| Device related |
|
| Study drug related |
|
| One or more unanticipated adverse device effects (ADEs) |
|
| One or more serious AEs |
|
| One or more serious ADEs (SADEs) |
|
| One or more serious unanticipated ADEs (USADEs) |
|
| Discontinuation due to an AE |
|