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Cochlear Implant With Dexamethasone Eluting Electrode Array

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ClinicalTrials.gov Identifier: NCT04750642
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : September 10, 2021
Sponsor:
Collaborators:
NAMSA
Avania
Vanderbilt University
Information provided by (Responsible Party):
Cochlear

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits. [ Time Frame: Six months ]
  2. Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Comparison of rate and type of device related adverse events between randomisation groups. [ Time Frame: Six months and twelve months ]
  2. 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. [ Time Frame: Six months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750642


Contacts
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Contact: Minal Menezes +61459377289 mmenezes@cochlear.com

Locations
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United States, Colorado
Rocky Mountain Ear Centre Not yet recruiting
Englewood, Colorado, United States, 80113
Contact: David Kelsall, Medical Doctor    3037839220      
Australia, New South Wales
Fiona Stanley Hospital Not yet recruiting
Murdoch, New South Wales, Australia, 6150
Contact: Jafri Kuthubutheen, MB BS, MB, FRACS    +61 8 6152 2222    jafri.kuthubutheen@health.wa.gov.au   
Principal Investigator: Jafri Kuthubutheen, MB BS, MB, FRACS         
Royal Prince Alfred Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2050
Contact: Catherine Birman, MB BS, FRACS    +61 2 9515 6111    catherine.birman@scic.org.au   
Principal Investigator: Catherine Birman, MB BS, FRACS         
Westmead Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2145
Contact: Melville da Cruz, FRANCS, MSc MD    +61 2 8890 5555    melville.dacruz@sydney.edu.au   
Principal Investigator: Melville da Cruz, FRACS, MSc MD         
Australia, Victoria
Royal Victorian Eye and Ear Hospital Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Stephen O'Leary, MB BS, MB, FRACS    +61 03 9929 8666    sjoleary@unimelb.edu.au   
Sponsors and Collaborators
Cochlear
NAMSA
Avania
Vanderbilt University
More Information
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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT04750642    
Other Study ID Numbers: CLTD5759
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Cochlear:
Cochlear Implant
Dexamethasone
Bilateral Hearing Loss
Sensorineural Hearing Loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases