Status:
RECRUITING
Robotic-Assisted Versus Manual Electrode Array Insertion
Lead Sponsor:
University of Iowa
Conditions:
Cochlear Implantation
Robotics
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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, roboti...
Detailed Description
Electrode insertion force is a critical determinant of the degree/amount of intracochlear trauma caused by CI surgery. It is affected by the speed of electrode array insertion, with higher insertion s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06951594
Start Date
June 30 2025
End Date
August 31 2028
Last Update
July 17 2025
Active Locations (1)
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1
University of Iowa Healthcare
Iowa City, Iowa, United States, 52242