Hearing Loss, SensorineuralINCATNCT06218966
Usability of the Intracochlear Catheter INCAT - a Feasibility Study
A study testing intracochlear catheter in people with Hearing Loss, Sensorineural and Hearing Loss, Cochlear, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- What is being tested?
- intracochlear catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre Otolaryngology Department
Toronto, Ontario, M4N 3M5
Trung Le, MD, PhD, 416-480 ext. 4141, trung.le@sunnybrook.de
About this study
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.
- Being tested
- intracochlear catheter
- Keywords
- hearing preservation, cochlear implant, intracochlear catheter, steroids, INCAT, sensorineural hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracochlear catheterDevice
intracochlear administration of steroids through the intracochlear catheter INCAT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: intracochlear catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
speech audiometry
CNC, AzBio, HINT
Measured: 12 months
Impedance
Impedance testing for all electrodes
Measured: 12 months
ECAPs
electrically evoked compound action potential testing for all electrodes
Measured: 12 months
ECochG
electrocochleargraphy
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- feasibility study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218966
- Sponsor's protocol ID
- INCAT
- Acronym
- INCAT
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on request
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 36969846Prenzler 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 29761349Prenzler 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the Intracochlear Catheter INCAT - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06218966
- Acronym / sponsor ID
- INCAT / INCAT
- Keywords
- hearing preservation, cochlear implant, intracochlear catheter, steroids, INCAT, sensorineural hearing loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- feasibility study
| Arm | Type | Receives |
|---|---|---|
| study group with INCAT | Experimental | Device: intracochlear catheterstudy group with patients receiving intracochlear steroid treatment with the intracochlear catheter INCAT prior to application of the cochlear implant electrode array |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracochlear catheterintracochlear administration of steroids through the intracochlear catheter INCAT | Device | study group with INCAT |
Primary outcome
Pure tone average with air and bone conduction
Time frame: 12 Months
air and bone conduction of the frequencies 0.25, 0.5, 1, 2, 4, 6, 8 kHz
speech audiometry
Time frame: 12 months
CNC, AzBio, HINT
Impedance
Time frame: 12 months
Impedance testing for all electrodes
ECAPs
Time frame: 12 months
electrically evoked compound action potential testing for all electrodes
ECochG
Time frame: 12 months
electrocochleargraphy
1 secondary outcome
Tinnitus
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 36969846Yildiz 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.
- Background: PubMed 29761349Prenzler 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.
- Background: PubMed 32390924Prenzler 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.
- Individual participant dataSharing planned: Yes. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracochlear catheter in people with Hearing Loss, Sensorineural and Hearing Loss, Cochlear, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trung Le, MD, PhD (416-480 ext. 4141, trung.le@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone average with air and bone conduction (time frame: 12 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218966, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.