Recruiting

Robotics vs. ManualRobotic-Assisted Versus Manual Electrode Array Insertion

Sponsor:

University of Iowa

Code:

NCT06951594

Conditions

Cochlear Implantation

Robotics

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Robotic

Study Details

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

Study ID

NCT06951594

Start date

Jun 30, 2025

Status verified date

Jun, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Robotic

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rachel Scheperle, PhD

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

Camille Dunn, PhD

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

Locations

University of Iowa Healthcare

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Rachel Scheperle, PhD

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

Camille Dunn, PhD

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

Principal Investigator:

Bruce Gantz, MD

More Information

Sponsor

University of Iowa

Last update posted

Jul 17, 2025

Last verified

Jun, 2025

Keywords

cochlear implantation
robotics
hearing preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-07-17.