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Recruiting NCT06936449

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

— Observational Sensorineural Hearing Loss Bilateral Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CI632D, CI632.
Who it may be relevant to
Registry conditions: Sensorineural Hearing Loss, Bilateral Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation. [Time frame: 5 years post-activation]
  • Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. [Time frame: 5 years post-activation]
  • Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation. [Time frame: 5 years post-activation]
  • Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. [Time frame: 5 years post-activation]
  • Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. [Time frame: 5 years post-activation]

Eligibility criteria

Inclusion criteria

  • Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
  • Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
  • Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  • Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Rocky Mountain Ear Center — Englewood
  • University of Iowa — Iowa City
  • University Hospitals Cleveland — Cleveland

Identifiers

NCT: NCT06936449 · CLTD5759-S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗