Status:
UNKNOWN
Usability of the Intracochlear Catheter INCAT - a Feasibility Study
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Hearing Loss, Sensorineural
Hearing Loss, Cochlear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a feasibility study for a inner ear catheter which will be used to apply steroids to the inner ear. It will be used on nearly deaf patients during their surgery, when they receive an implant t...
Detailed Description
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 cochle...
Eligibility Criteria
Inclusion
- Adults, 18 years of age or older at the time of implantation
- Moderate to profound hearing loss in the low frequencies and severe to profound hearing
- Loss in the high frequencies, bilaterally as defined by (see Figure 4A and B below for example audiogram information)
- Low-frequency pure tone average (PTA - 250, 500, and 1000 Hz) greater than 40 dB
- High-frequencies not better than 65 decibels (3000 Hz - 8000 Hz)
- Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10 dB
- Limited benefit from appropriately fit hearing aids, defined by consonant-nucleus-consonant (CNC) word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
- CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
- Fluent in English
- No radiological contraindications
- Ability to undergo general anesthesia
- Appropriate motivation and expectation levels
- Stated willingness to comply with all study procedures for the duration of the study
- Able to perform subjective hearing tests
- Able to fill out questionnaires
Exclusion
- Age less than 18 years
- Not willing to provide informed consent
- Unable to perform subjective hearing tests
- Unable to fill out questionnaires
- Previous unsensitivity to the investigated drug
- Unable to follow the protocol for any reasons
- Evidence that hearing loss is retrocochlear in origin
- Active middle ear infection
- Skin or scalp condition precluding use of external audio processor
- Suspected cognitive impairment or organic brain dysfunction
- History of prior use of a hearing implant
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06218966
Start Date
January 15 2024
End Date
June 1 2024
Last Update
January 23 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre Otolaryngology Department
Toronto, Ontario, Canada, M4N 3M5