iotaSOFT Pediatric Study

July 14, 2026 updated by: iotaMotion, Inc.

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices
  • Age 9 months to less than 12 years old at the time of CI surgery
  • Willingness to participate in the study and able to comply with the follow-up visit requirements

Exclusion Criteria:

  • Prior cochlear implantation in the ear to be implanted
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion
  • Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
  • Deafness due to lesions of the acoustic nerve or central auditory pathway
  • Diagnosis of auditory neuropathy.
  • Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
  • Absence of cochlear development
  • Additional medical concerns that would prevent participation in evaluations as determined by the investigator
  • Planned or current participation in a clinical study of an investigational device or drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric Cochlear Implant Recipient
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age who meet prescribed inclusion and exclusion criteria per protocol, signing and Informed Consent and completing active study period; enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
Device: iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs.
Time Frame: (SAEs) through 30 days after CI surgery/activation
The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
(SAEs) through 30 days after CI surgery/activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iotaMotion, Inc.

Investigators

  • Study Director: Laura Chenier, iotaMotion, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

October 24, 2024

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iotaSOFT000002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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