Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424262
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant CI622
Sponsor:
Cochlear
Organization:
Cochlear
Study Overview
Official Title:
A Pivotal Prospective Multi-centre Randomised Controlled 6-month Blinded Investigation Followed by a 6-month Open-label Phase Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode CI622D in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode CI622 in a Newly Implanted Adult Population With Post-linguistic Bilateral Moderately Severe to Profound Sensorineural Hearing Loss
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT
Brief Summary:
This clinical study will test a newly developed cochlear implant known as CI622D This experimental cochlear implant has been designed to slowly release a drug called dexamethasone Dexamethasone works to ease inflammation which is common after any surgical procedure The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant CI622D vs the standard cochlear implant CI622 without dexamethasone The study will be conducted in adults with sensorineural hearing loss a type of hearing loss caused by damage to the inner ear or auditory nerve The study participants will undergo a series of tests that include testing their implant and their hearing They will also complete questionnaires to see how they rate their hearing ability and their overall general health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None