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โ† Trials
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Robotic-Assisted Versus Manual Electrode Array Insertion

RecruitingNAAges 18 Years - 80 YearsAllBruce J Gantz
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In plain words

What the trial is, and whether it could suit you

Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and/or the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Candidate for a cochlear implant according to CMS guidelines * Willingness to comply with all study requirements * Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging * English speaking Exclusion Criteria: * Medical or psychological conditions that contraindicate undergoing surgery * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. * Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
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What it tests

  • Robotic
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Where

1 site
University of Iowa Healthcare
Iowa City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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