Clinical trial NCT04750642: Cochlear Implant With Dexamethasone Eluting Electrode Array
Official title: Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Bilateral Hearing Loss
Keywords: Cochlear Implant
Dexamethasone
Bilateral Hearing Loss
Sensorineural Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
name: Avania
name: Vanderbilt University
First posted: 2021-02-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative
timeFrame: Six months postoperative
measure: Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D
timeFrame: Six months postoperative
Secondary outcomes:
measure: Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
timeFrame: Twelve months postoperative
measure: Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative
timeFrame: Six months postoperative
measure: Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative
timeFrame: Six months postoperative
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Ear Centre
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New York
country: United States
facility: New York Eye & Ear infirmary of Mt. Sinai
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Gilles Hospital
Study officials:
affiliation: Cochlear
name: Aaron Parkinson
role: STUDY_DIRECTOR
References: