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RECRUITING
NCT06664697

Post-Market Clinical Investigation of the IotaSOFT Insertion System

Sponsor: iotaMotion, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-10-01

Completion Date

2025-12-31

Last Updated

2024-10-31

Healthy Volunteers

No

Interventions

DEVICE

Cochlear Implantation with Robotic-Assisted Insertion System

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.

Locations (3)

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Oregon Health and Sciences University

Portland, Oregon, United States