RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06936449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
  2. * Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
  3. * Willing and able to provide written informed consent.
  1. * 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.
  2. * Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  3. * Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
  4. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Contacts and Locations

Study Contact

Aaron Parkinson
CONTACT
800 523 5798
aparkinson@cochlear.com

Study Locations (Sites)

Rocky Mountain Ear Center
Englewood, Colorado, 80113
United States

Collaborators and Investigators

Sponsor: Cochlear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2028-03

Study Record Updates

Study Start Date2025-04
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • cochlear implant
  • dexamethasone
  • bilateral hearing loss
  • sensorineural hearing loss

Additional Relevant MeSH Terms

  • Sensorineural Hearing Loss
  • Bilateral Hearing Loss