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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Iowa
University of Iowa Healthcare
RECRUITING
Iowa City
Contact Information
Primary
Rachel Scheperle, PhD
oto-electrophys@uiowa.edu
319-384-9031
Backup
Camille Dunn, PhD
camille-dunn@uiowa.edu
319-353-8776
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov