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The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear Implant Recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Objective measures with CSEP | Device | Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over | Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm. | at surgery, within one minute |
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Inclusion Criteria:
Exclusion Criteria:
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Routine patients undergoing a standard cochlear implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Bart Volckaerts, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEARing CRC | Carlton | Australia | ||||
| Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35306487 | Derived | Hoppe U, Brademann G, Stover T, Ramos de Miguel A, Cowan R, Manrique M, Falcon-Gonzalez JC, Hey M, Baumann U, Huarte A, Liebscher T, Bennett C, English R, Neben N, Ramos Macias A. Evaluation of a Transimpedance Matrix Algorithm to Detect Anomalous Cochlear Implant Electrode Position. Audiol Neurootol. 2022;27(5):347-355. doi: 10.1159/000523784. Epub 2022 Mar 18. |
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153 participants were recruited in six centres from 03 October 2017 to 29 May 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear Implant Recipients | CI532 and CI512 cochlear implant recipients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
153 participants were recruited and one patient withdrew consent. The data of this participant were not analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear Implant Recipients | CI532 and CI512 cochlear implant recipients |
| 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 | Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over | Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm. | 148 ears were analyzed from 145 participants (with three bilateral participants providing 148 ears). From the 152 baseline participants, seven were excluded from the analysis: for three participants, no transimpedance data were obtained intra-operatively and for four participants the transimpedance data showed measurement abnormalities. | Posted | Number | 90% Confidence Interval | Percentage of ears | at surgery, within one minute | ears | ears |
|
3 months
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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 | Cochlear Implant Recipients | CI532 and CI512 cochlear implant recipients | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal carcinoma | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Neben | Cochlear | +4951154277220 | nneben@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2018 | May 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2017 | Jun 5, 2020 | SAP_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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| Erlangen |
| Germany |
| Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität | Frankfurt am Main | Germany |
| Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie | Kiel | Germany |
| Complejo Hospitalario Universitario Insular Materno Infantil | Las Palmas de Gran Canaria | Spain |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| 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 | Count of Participants | Participants |
|
|
|
| 153 |
| 2 |
| 153 |
| 0 |
| 153 |
| Pass out related to heat | General disorders | Non-systematic Assessment |
|
Investigators can publish and/or present their own data and process their data with their own algorithms. At study end 2 joint publications by the clinical investigators/sponsor are planned with the Coordinating Investigator writing the publication. All abstract/publication must be reviewed by the sponsor at least 30 days in advance. If a publication contains information that the sponsor finds worth protecting the sponsor has the right to delay the publication/presentation for 90 days.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |