Usability of the Intracochlear Catheter INCAT - a Feasibility Study

NCT06218966 | Unknown

• 1 other identifier: INCAT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 that will restore the hearing. Treatment with steroids will improve the maintenance of residual hearing, which will be tested during and after the surgery.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Cochlear

Keywords

hearing preservation; cochlear implant; intracochlear catheter; steroids; INCAT; sensorineural hearing loss

Outcome Measures

Primary Outcomes (5)

• Pure tone average with air and bone conduction

  air and bone conduction of the frequencies 0.25, 0.5, 1, 2, 4, 6, 8 kHz

  12 Months

• speech audiometry

  CNC, AzBio, HINT

  12 months

• Impedance

  Impedance testing for all electrodes

  12 months

• ECAPs

  electrically evoked compound action potential testing for all electrodes

  12 months

• ECochG

  electrocochleargraphy

  12 months

Secondary Outcomes (1)

• Tinnitus

  12 Months

Study Arms (1)

study group with INCAT

EXPERIMENTAL

study group with patients receiving intracochlear steroid treatment with the intracochlear catheter INCAT prior to application of the cochlear implant electrode array

Device: intracochlear catheter

Interventions

intracochlear catheter DEVICE

intracochlear administration of steroids through the intracochlear catheter INCAT

study group with INCAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre Otolaryngology Department

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

• Yildiz E, Gadenstaetter AJ, Gerlitz M, Landegger LD, Liepins R, Nieratschker M, Glueckert R, Staecker H, Honeder C, Arnoldner C. Investigation of inner ear drug delivery with a cochlear catheter in piglets as a representative model for human cochlear pharmacokinetics. Front Pharmacol. 2023 Mar 9;14:1062379. doi: 10.3389/fphar.2023.1062379. eCollection 2023.

  PMID: 36969846 BACKGROUND

• Prenzler NK, Salcher R, Timm M, Gaertner L, Lenarz T, Warnecke A. Intracochlear administration of steroids with a catheter during human cochlear implantation: a safety and feasibility study. Drug Deliv Transl Res. 2018 Oct;8(5):1191-1199. doi: 10.1007/s13346-018-0539-z.

  PMID: 29761349 BACKGROUND

• Prenzler NK, Salcher R, Lenarz T, Gaertner L, Warnecke A. Dose-Dependent Transient Decrease of Impedances by Deep Intracochlear Injection of Triamcinolone With a Cochlear Catheter Prior to Cochlear Implantation-1 Year Data. Front Neurol. 2020 Apr 15;11:258. doi: 10.3389/fneur.2020.00258. eCollection 2020.

  PMID: 32390924 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trung Le, MD, PhD

CONTACT

416-480; trung.le@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: feasibility study

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: January 23, 2024
• Study Start: January 15, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: in 12 months and for 12 months
• Access Criteria: please contact the PI

Locations

CA (1)