Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-29
Brief Title:
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
BULLS-I
Brief Summary:
This is a prospective multicenter multinational randomized control trial The duration of the study for the individual patient will be approximately 1 year pre-operative assessments 1 week 3 months and 12 months follow-up assessments Participants will be randomized to one of two surgical approaches eRW or CO with a 11 allocation in a parallel design
Detailed Description:
Rationale Preserving residual hearing in cochlear implant CI surgery has gained significant attention It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation enhancing sound localization music appreciation and speech recognition in noisy environments Using the Cochlear Nucleus CI with Slim Modiolar electrode Cochlear Ltd Sydney Australia potential sites of residual hearing loss in surgery include approaches to the cochlear lumen potential damage during entry and damage during electrode insertion Studies comparing different surgical approaches cochleostomy CO and extended round window eRW show varied results Electrocochleography ECochG can be used to indicate intracochlear damage during electrode insertion however the variability observed in ECochG responses during cochlear implantation remains significant Moreover ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery including the insertion of the sheath or stabilization of the electrode lead
Objective The aim of this study is to investigate whether the type of surgical approach to the cochlea CO or eRW using the CI632 affects the final residual hearing and secondarily intracochlear trauma and electrode position as determined by pure tone audiometry EcochG and imaging
Study population Adult CI candidates with post-lingual onset of severe to profound hearing loss who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of 80 decibel dB hearing level at 500 Hz in the ear to be implanted
Objective The aim of this study is to investigate whether the type of surgical approach to the cochlea CO or eRW using the CI632 affects the final residual hearing and secondarily intracochlear trauma and electrode position as determined by pure tone audiometry EcochG and imaging
Study population Adult CI candidates with post-lingual onset of severe to profound hearing loss who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of 80 decibel dB hearing level at 500 Hz in the ear to be implanted
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