Usability of the Intracochlear Catheter INCAT - a Feasibility Study : Usability of the Intracochlear Catheter INCAT - a Feasibility Study
Study Device: The INCAT is an intracochlear catheter which is eligible in Canada for intracochlear drug delivery.Summary: 24 patients with moderate to profound hearing loss and indication for cochlear implantation will receive intracochlear treatment with steroids with an intracochlear catheter (INCAT) for hearing preservation prior to insertion of the cochlear implant array. Subjects will be considered for the study if they are 18 years of age or older and demonstrate a CNC word score in quiet of 60% or less in the ear to be implanted. Subjects will be followed for 6 months post-activation of the audio processor.Primary Objectives: Determination of feasibility of the intracochlear catheter INCAT and hearing preservation of residual hearing thresholds intra-, postoperatively, and long-term.Secondary Objectives: Assessment of quality of life, tinnitus and development of speech perception with the implant up to one year after implantation.Study Endpoint: Feasibility of using the INCAT and assessment of hearing preservation of residual hearing thresholds. Impedance field telemetry will help to assess hearing thresholds pre-, peri-, and postinsertion..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 23. Jan. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 23, 2024, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2024, Last updated: January 31, 2024 |
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| PPN (Katalog-ID): |
CTG009565604 |
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| 520 | |a Study Device: The INCAT is an intracochlear catheter which is eligible in Canada for intracochlear drug delivery.Summary: 24 patients with moderate to profound hearing loss and indication for cochlear implantation will receive intracochlear treatment with steroids with an intracochlear catheter (INCAT) for hearing preservation prior to insertion of the cochlear implant array. Subjects will be considered for the study if they are 18 years of age or older and demonstrate a CNC word score in quiet of 60% or less in the ear to be implanted. Subjects will be followed for 6 months post-activation of the audio processor.Primary Objectives: Determination of feasibility of the intracochlear catheter INCAT and hearing preservation of residual hearing thresholds intra-, postoperatively, and long-term.Secondary Objectives: Assessment of quality of life, tinnitus and development of speech perception with the implant up to one year after implantation.Study Endpoint: Feasibility of using the INCAT and assessment of hearing preservation of residual hearing thresholds. Impedance field telemetry will help to assess hearing thresholds pre-, peri-, and postinsertion. | ||
| 650 | 2 | |a Hearing Loss | |
| 650 | 2 | |a Deafness | |
| 650 | 2 | |a Hearing Loss, Sensorineural | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
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