Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Cochlear
Study ID
NCT06936449
Status
Recruiting
Apply to this trial

Conditions

  • Bilateral Hearing Loss
  • Sensorineural Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CI632D — DEVICE
    CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
  • CI632 — DEVICE
    CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Study Details

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Key Dates

Start date
May 5, 2025
Status verified
May 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
19 participants (estimated)

Arms

  • Arm: Experimental: CI632D Investigational Medical Device (IMD)
    Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
  • Arm: Active Comparator: CI632 Comparator Device
    Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant

Primary Outcome Measure

Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits. [ Time Frame: 5 years post-activation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rocky Mountain Ear CenterEnglewoodColorado80113
Aaron Parkinson
[email protected]
800 523 5798
David Kelsall, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Aaron Parkinson
[email protected]
800 523 5798
Bruce Gantz, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals ClevelandClevelandOhio44106
Aaron Parkinson
[email protected]
800 523 5798
Alejandro Rivas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Englewood, CO

By research site
Rocky Mountain Ear Center· Englewood, COUniversity of Iowa· Iowa City, IAUniversity Hospitals Cleveland· Cleveland, OH

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