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study group with INCAT for Sensorineural Hearing Loss (INCAT Trial)

N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10 dB
Ability to undergo general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

INCAT Trial Summary

This trial is testing a new device that can deliver steroids to the inner ear. The device will be used during surgery for patients who are almost completely deaf. These patients will also be receiving an implant to

Who is the study for?
This clinical trial is for individuals who are nearly deaf due to sensorineural or cochlear hearing loss and are scheduled to receive an implant that will restore their hearing. The study aims to test a new method of applying steroids directly to the inner ear during surgery.Check my eligibility
What is being tested?
The intervention being studied is an intracochlear catheter designed for direct steroid application in the inner ear. This feasibility study will assess its usability and effectiveness in preserving residual hearing during and after cochlear implant surgery.See study design
What are the potential side effects?
Since this is a feasibility study, specific side effects related to the intracochlear catheter have not been detailed but may include risks associated with surgical procedures and local steroid application.

INCAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a type of hearing loss where the issue lies in my inner ear.
Select...
I can safely be put under general anesthesia.
Select...
My hearing aids don't help much; my word understanding score is 60% or less in one ear and 70% or less in the other.
Select...
I am 18 years old or older.

INCAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ECAPs
ECochG
Impedance
+2 more
Secondary outcome measures
Tinnitus

INCAT Trial Design

1Treatment groups
Experimental Treatment
Group I: study group with INCATExperimental Treatment1 Intervention
study group with patients receiving intracochlear steroid treatment with the intracochlear catheter INCAT prior to application of the cochlear implant electrode array

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,283 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process still open for individuals interested in participating in this trial?

"According to the information available on clinicaltrials.gov, this trial is currently not seeking participants. The trial was initially posted on January 15th, 2024 and last updated on January 22nd, 2024. However, it's important to note that there are still 180 other studies actively accepting patients at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Usability of the Intracochlear Catheter INCAT - a Feasibility Study
2024. "Usability of the Intracochlear Catheter INCAT - a Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218966.
All > Sensorineural Hearing Loss > Cochlear Implant
~0 spots leftby Jun 2024
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