RECRUITING

Robotic-Assisted Versus Manual Electrode Array Insertion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion

Quick Facts

Study Start:2025-06-30
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06951594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Candidate for a cochlear implant according to CMS guidelines
  2. * Willingness to comply with all study requirements
  3. * Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging
  4. * English speaking
  1. * Medical or psychological conditions that contraindicate undergoing surgery
  2. * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  3. * 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.

Contacts and Locations

Study Contact

Rachel Scheperle, PhD
CONTACT
319-384-9031
oto-electrophys@uiowa.edu
Camille Dunn, PhD
CONTACT
319-353-8776
camille-dunn@uiowa.edu

Principal Investigator

Bruce Gantz, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Healthcare
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Bruce Gantz, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • cochlear implantation
  • robotics
  • hearing preservation

Additional Relevant MeSH Terms

  • Cochlear Implantation
  • Robotics