Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598059
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pivotal Prospective Multicentre Single-arm Study Evaluating the Safety and Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode Array EA32D
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEE-REX
Brief Summary:
This clinical study will test a new type of cochlear implant known as CI632D This experimental cochlear implant has been designed to slowly release a drug called dexamethasone Dexamethasone works to ease inflammation and reduce tissue injury which is common after any type of surgery The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well or even better in improving hearing than what would be expected with a standard cochlear implant 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 nerve that carries sound signals from the ear to the brain The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None