Usability of the Intracochlear Catheter INCAT - a Feasibility Study (INCAT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Cochlear
• Intervention / Treatment: Device: intracochlear catheter

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trung Le, MD, PhD; Phone Number: 4141 416-480; Email: trung.le@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre Otolaryngology Department
      • Contact: Trung Le, MD, PhD; Phone Number: 4141 416-480; Email: trung.le@sunnybrook.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group with INCAT; 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; intracochlear administration of steroids through the intracochlear catheter INCAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus	Assessment of tinnitus with Tinnitus Handicap Inventory, which is a 25-item self-report measure to determine perceived tinnitus handicap severity	12 Months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: hearing preservation; cochlear implant; steroids; sensorineural hearing loss; intracochlear catheter; INCAT
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: INCAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: on request
• IPD Sharing Time Frame: in 12 months and for 12 months
• IPD Sharing Access Criteria: please contact the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No