Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
iotaMotion, Inc.
Study ID
NCT06664710
Status
Recruiting
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Conditions

  • Cochlear Implantation
  • Hearing Loss, Sensorineural

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • iotaSOFT Insertion System with AIM — DEVICE
    Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
  • iotaSOFT Insertion System with AIM Control — DEVICE
    iotaSOFT Insertion System with AIM using standard of care insertion techniques

Study Details

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Key Dates

Start date
Jan 17, 2024
Status verified
Jan 2025
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Active Comparator: Control
    Use of the iotaSOFT Insertion System and AIM based on Standard of Care
  • Experimental: Experimental
    Use of iotaSOFT Insertion System with AIM experimental device

Primary Outcome Measure

Device Feasibility [ Time Frame: Procedure Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IA

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