Post-Market Clinical Investigation of the IotaSOFT Insertion System

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
iotaMotion, Inc.
Study ID
NCT06664697
Status
Recruiting
Apply to this trial

Conditions

  • Cochlear Implantation
  • Hearing Loss, Cochlear
  • Hearing Loss, Sensorineural

Eligibility Criteria

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

Interventions

  • Cochlear Implantation with Robotic-Assisted Insertion System — DEVICE
    The purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System.

Study Details

The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject

Key Dates

Start date
Oct 1, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Retrospective
    Retrospective Review of patient records
  • Arm: Prospective
    Prospective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant

Primary Outcome Measure

Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery [ Time Frame: 1 month post-activation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Leila Partoo
[email protected]
317-278-1238
Rick Nelson, MD
University of IowaIowa CityIowa52242
Camille Dunn, AuD
[email protected]
319-356-3574
Bruce Gantz, MD
Oregon Health and Sciences UniversityPortlandOregon97239
Jess Mace
[email protected]
503-494-5886
Jay Gantz, MD

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By research site
Indiana University· Indianapolis, INUniversity of Iowa· Iowa City, IAOregon Health and Sciences University· Portland, OR

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