Actively Recruiting
Robotic-Assisted Versus Manual Electrode Array Insertion
Led by University of Iowa · Updated on 2025-07-17
100
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Robotic-Assisted Versus Manual Electrode Array Insertion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 regarding the benefits, risks, and limitations of the surgery and prosthetic device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Iowa Healthcare
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
R
Rachel Scheperle, PhD
CONTACT
C
Camille Dunn, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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