Robotic-Assisted Versus Manual Electrode Array Insertion

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT06951594
Status
Recruiting
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Conditions

  • Cochlear Implantation
  • Robotics

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic — DEVICE
    The iotaSOFT™ Insertion System is an FDA approved cochlear implant (CI) electrode array insertion tool. It provides surgeons with consistent insertion speed and force. The system consists of a drive unit connected to a touch screen control console and foot pedal interface. The surgeon secures the base to the skull with two pre-loaded self-drilling bone screws. The drive unit is placed into the base and the adjustable drive head is coupled to a CI electrode. Before insertion begins, the surgeon selects the desired speed of insertion. the surgeon controls the electrode insertion forward and reverse motion via foot pedal while guiding the electrode array into the cochlea with standard CI instrumentation. Upon the completion of electrode array insertion, the drive head and unit are uncoupled from the electrode lead and removed from the patient for disposal.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Robot
    The iotaSOFT™ Insertion System is an FDA approved cochlear implant (CI) electrode array insertion tool. It will be used to assist the surgeon with the cochlear implant insertion.
  • No Intervention: Manual
    Manual cochlear implant surgical procedure without robotic assistance.

Primary Outcome Measure

scalar translocation [ Time Frame: Postoperative standard of care CT (approximately at activation or 2 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa HealthcareIowa CityIowa52242
Rachel Scheperle, PhD
[email protected]
319-384-9031
Camille Dunn, PhD
[email protected]
319-353-8776
Bruce Gantz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Iowa Healthcare· Iowa City, IA

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