Health TrialsbyHealthPanel

Robotic-Assisted Versus Manual Electrode Array Insertion

ConditionsCochlear ImplantationRobotics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Iowa

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: RobotExperimental treatment 1 intervention
Group B: ManualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

scalar translocation

Postoperative CT scan will be used to assess scalar translocation

Time frame
Postoperative standard of care CT (approximately at activation or 2 weeks)
2

Angular Insertion depth

Angle of the electrode array inside the cochlea, measured relative to the round window membrane.

Time frame
Postoperative standard of care CT (approximately at activation or 2 weeks)

Secondary outcomes

1

Impedance

resistance to the flow of current for each active electrode

Time frame
initial activation and at 3 and 6 months post CI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Source ClinicalTrials.gov
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