Robotic-Assisted Versus Manual Electrode Array Insertion
Recruiting now · Not applicable
Conditions studied: Cochlear Implantation, Robotics
In brief
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.
Key facts
- Study ID
- NCT06951594
- Run by
- University of Iowa
- People needed
- 100
- Starts
- 2025-06-30
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2025-07-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Iowa Healthcare — Iowa City, Iowa, United States (enrolling)
Full record on ClinicalTrials.gov
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