NCT06951594 Robotic-Assisted Versus Manual Electrode Array Insertion
| NCT ID | NCT06951594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bruce J Gantz |
| Condition | Cochlear Implantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-06-30 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility Criteria
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.
Contact & Investigator
Bruce Gantz, MD
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT06951594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cochlear Implantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06951594 currently recruiting?
Yes, NCT06951594 is actively recruiting participants. Contact the research team at oto-electrophys@uiowa.edu for enrollment information.
Where is the NCT06951594 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06951594 clinical trial?
NCT06951594 is sponsored by Bruce J Gantz. The principal investigator is Bruce Gantz, MD at University of Iowa. The trial plans to enroll 100 participants.