Cochlear Implant With Dexamethasone Eluting Electrode Array

Sponsor

Cochlear (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04750642

Collaborator

NAMSA (Other), Avania (Industry), Vanderbilt University (Other)

120

Enrollment

Locations

Arms

32.9

Anticipated Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss Bilateral Hearing Loss	Device: CI632D Device: CI632	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CI632D Investigational Medical Device (IMD)	Device: CI632D CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
Placebo Comparator: CI632 Comparator Device	Device: CI632 CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Arm

Intervention/Treatment

Experimental: CI632D Investigational Medical Device (IMD)

Device: CI632D

CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)

Placebo Comparator: CI632 Comparator Device

Device: CI632

CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Outcome Measures

Primary Outcome Measures

Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits. [Six months]
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 Outcome Measures

Comparison of rate and type of device related adverse events between randomisation groups. [Six months and twelve months]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles(UCLA), Medical center	Los Angeles	California	United States	90095
2	Rocky Mountain Ear Centre	Englewood	Colorado	United States	80113
3	University of Iowa	Iowa City	Iowa	United States	52242
4	Mayo Clinic Rochester Foundation	Rochester	Minnesota	United States	55905
5	Washington University School of medicine	Saint Louis	Missouri	United States	63110
6	New York Eye & Ear infirmary of Mt. Sinai	New York	New York	United States	10010
7	NYU Langone Medical Center	New York	New York	United States	10017
8	University Hospitals Cleveland Medical center	Cleveland	Ohio	United States	44106
9	The Ohio State University Eye and Ear Institute at Wexner Medical Center	Columbus	Ohio	United States	43212
10	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
11	University of Utah Hospital and Clinics	Salt Lake City	Utah	United States	84132
12	University of Virginia Medical Center	Charlottesville	Virginia	United States	22903
13	Fiona Stanley Hospital	Murdoch	New South Wales	Australia	6150
14	Westmead Hospital	Sydney	New South Wales	Australia	2145
15	Royal Prince Alfred Hospital	Sydney	New South Wales	Australia	6150
16	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria	Australia	3002