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Robotic-Assisted Versus Manual Electrode Array Insertion

NCT06951594 · Bruce J Gantz · Updated 16 Oct 2026

What is being tested
Robotic
For
Cochlear Implantation; Robotics
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 100 people. The full rules are on the registry page.
Where
United States
When
Starts or started 30 June 2025, ends 31 Aug 2028. Registered 30 April 2025.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06951594

Sites

  • University of Iowa HealthcareIowa City, Iowa, United States