Robotic-Assisted Versus Manual Electrode Array Insertion

NCT06951594 | Recruiting DMC FDA Device

• 1 other identifier: 202210440
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implantation; Robotics

Keywords

cochlear implantation; robotics; hearing preservation

Outcome Measures

Primary Outcomes (2)

• scalar translocation

  Postoperative CT scan will be used to assess scalar translocation

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

• Angular Insertion depth

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

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

Secondary Outcomes (1)

• Impedance

  initial activation and at 3 and 6 months post CI

Study Arms (2)

Robot

EXPERIMENTAL

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.

Device: Robotic

Manual

NO INTERVENTION

Manual cochlear implant surgical procedure without robotic assistance.

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.

Robot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

RECRUITING

Study Officials

• Bruce Gantz, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Scheperle, PhD

CONTACT

319-384-9031; oto-electrophys@uiowa.edu

Camille Dunn, PhD

CONTACT

319-353-8776; camille-dunn@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Emeritus, Department of Otolaryngology--Head and Neck Surgery

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 30, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)