RecruitingNot ApplicableNCT06453343

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

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

Sponsor

Radboud University Medical Center

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hearing Loss, Sensorineural Cochlear Implants

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Surgical approach: cochleostomy or extended round window for people with cochlear implants and hearing loss, sensorineural. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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