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COMPLETED
NCT06106373
NA

iotaSOFT Pediatric Study

Sponsor: iotaMotion, Inc.

View on ClinicalTrials.gov

Summary

Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.

Official title: iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

Key Details

Gender

All

Age Range

9 Months - 12 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-05-17

Completion Date

2025-07-10

Last Updated

2026-08-06

Healthy Volunteers

Yes

Interventions

DEVICE

iotaSOFT Insertion System

robotic assistive technology for cochlear implant electrode insertion

Locations (2)

University of Iowa

Iowa City, Iowa, United States

Texas Childrens Hospital

Houston, Texas, United States