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Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Sponsor: Radboud University Medical Center
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 1:1 allocation in a parallel design.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-01-01
Completion Date
2027-11
Last Updated
2025-02-25
Healthy Volunteers
No
Interventions
Surgical approach: cochleostomy or extended round window
Surgical placement of a cochlear implant electrode array
Locations (1)
Radboud University Medical Center
Nijmegen, Netherlands