Actively Recruiting
Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion
Led by University of Iowa · Updated on 2025-07-17
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing robotic-assisted electrode array insertion to manual insertion in cochlear implant surgery to see if the robotic method reduces trauma and improves outcomes. This study focuses on adults eligible for cochlear implants and evaluates how robotic control of insertion speed and force might preserve inner ear structures and function better than manual methods. The primary goal is to understand if this advanced technology leads to better hearing preservation and speech perception after surgery. The study involves two groups: one using the FDA-approved iotaSOFT™ robotic insertion system and the other undergoing standard manual cochlear implant surgery. The robotic system allows precise control of insertion speed between 0.1-1.0 mm/sec and reduces force variability, which has shown benefits in cadaver studies. Surgeons use a drive unit with foot pedal control to insert the electrode array carefully. The manual group receives the usual electrode insertion without robotic assistance. Participants will undergo postoperative CT scans to assess cochlear trauma, as well as evaluations of electrode impedance and auditory nerve function using ECochG and eCAP. Hearing preservation and speech perception are also measured over time. Follow-up visits occur at activation and at 3 and 6 months post-implant. This research aims to provide detailed information on structural and functional outcomes after cochlear implant surgery, helping to guide future surgical practices.
CONDITIONS
Brief 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 confirmed by preoperative imaging
- English speaking
You will not qualify if you...
- Medical or psychological conditions that contraindicate undergoing surgery
- Ossification or cochlear anomalies preventing complete electrode array insertion
- Unrealistic expectations regarding benefits, risks, and limitations of surgery and devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo cochlear implant surgery with either robotic-assisted or manual electrode array insertion.
1 surgical visit (in-person)
Duration - Up to 6 months
Participants receive standard post-operative care including CT scans and assessments of cochlear implant function.
1 CT scan visit around 2 weeks post-surgery and visits at initial activation, 3 months, and 6 months post-implant
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
C
Camille Dunn, PhD
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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