Long-term follow-up of a cochlear implant with a drug-eluting electrode
Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
This study looks at how a special cochlear implant that releases a medication affects hearing over time in people with hearing loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 3 sites (Englewood, Colorado and 2 other locations) |
| Trial ID | NCT06936449 on ClinicalTrials.gov |
What this trial studies
This study involves a long-term follow-up of patients who have received a cochlear implant with a dexamethasone-eluting electrode array. The aim is to observe the effects of the implant on sensorineural and bilateral hearing loss over time, particularly focusing on the reduction of inflammatory responses due to the drug elution. Participants must have previously completed obligations of a related study and be willing to provide informed consent. The study is observational and does not involve new interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in the CLTD5759 study and received a CI632D or CI632 cochlear implant.
Not a fit: Patients with unrealistic expectations about the benefits of the cochlear implant or those with additional disabilities affecting participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients with hearing loss by minimizing inflammation associated with cochlear implants.
How similar studies have performed: Other studies involving drug-eluting devices have shown promise in reducing inflammation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Englewood, Colorado and 2 other locations
- Rocky Mountain Ear Center — Englewood, Colorado, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University Hospitals Cleveland — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Aaron Parkinson
- Email: aparkinson@cochlear.com
- Phone: 800 523 5798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.