Cochlear Implant With Dexamethasone Eluting Electrode Array

Sensorineural Hearing Loss Clinical Trial

Official title:

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04750642
• Other study ID #: CLTD5759
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2023
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Description:

The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-lingual, bilateral, moderate (= 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, = 90 dB HL.

• 18 years or older at time of consent.

Exclusion Criteria:

• Abnormal cochlear and middle ear anatomy

• History with cochlear implant surgery

• Allergy to dexamethasone

• Women who are pregnant or plan to become pregnant

• Unable/unwilling to comply to study requirements

Related Conditions & MeSH terms

• Bilateral Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• CI632D
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
• CI632
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Locations

Country	Name	City	State
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
New Zealand	Gilles Hospital	Auckland
New Zealand	St. George Hospital	Christchurch
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University Hospitals Cleveland Medical center	Cleveland	Ohio
United States	The Ohio State University Eye and Ear Institute at Wexner Medical Center	Columbus	Ohio
United States	Rocky Mountain Ear Centre	Englewood	Colorado
United States	University of Iowa	Iowa City	Iowa
United States	University of California Los Angeles(UCLA), Medical center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Eye & Ear infirmary of Mt. Sinai	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Michigan Ear Institute	Novi	Michigan
United States	Hearts for Hearing	Oklahoma City	Oklahoma
United States	Mayo Clinic Rochester Foundation	Rochester	Minnesota
United States	Washington University School of medicine	Saint Louis	Missouri
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Cochlear	Avania, NAMSA, Vanderbilt University

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.		Six months
Primary	Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits.		Six months
Secondary	Comparison of rate and type of device related adverse events between randomisation groups.		Six months and twelve months
Secondary	Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit.		Six months