CClinicalTrials.gg
Sign In
Not yet recruitingNCT06218966INCATUpdated Jan 23, 2024

Usability of the Intracochlear Catheter INCAT - a Feasibility Study

An interventional study of intracochlear catheter in Hearing Loss, Sensorineural and Hearing Loss, Cochlear, sponsored by Sunnybrook Health Sciences Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hearing Loss, Sensorineural
  • Hearing Loss, Cochlear

Keywords

  • hearing preservation
  • cochlear implant
  • intracochlear catheter
  • steroids
  • INCAT
  • sensorineural hearing loss
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 24 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

Interventions

  • Deviceintracochlear catheter

    intracochlear administration of steroids through the intracochlear catheter INCAT

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 Months

  2. speech audiometry

    CNC, AzBio, HINT

    Time frame: 12 months

  3. Impedance

    Impedance testing for all electrodes

    Time frame: 12 months

  4. ECAPs

    electrically evoked compound action potential testing for all electrodes

    Time frame: 12 months

  5. ECochG

    electrocochleargraphy

    Time frame: 12 months

Secondary outcomes

  1. Tinnitus

    Assessment of tinnitus with Tinnitus Handicap Inventory, which is a 25-item self-report measure to determine perceived tinnitus handicap severity

    Time frame: 12 Months

07

Study locations

1 site
  • Sunnybrook Health Sciences Centre Otolaryngology Department
    Toronto, Ontario M4N 3M5, Canada
08

References and documents

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. PubMed 36969846 ↗
  • 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. PubMed 29761349 ↗
  • 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. PubMed 32390924 ↗

Individual participant data

Plan to share: Yes — on request

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06218966
Lead sponsor
Sunnybrook Health Sciences Centre
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
Jan 15, 2024 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jan 23, 2024

Study contacts

Trung Le, MD, PhD
Contact
trung.le@sunnybrook.ca
416-480 ext. 4141

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hearing Loss→

Other studies from this sponsor

Sunnybrook Health Sciences Centre

Start the discussion