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iotaSOFT Pediatric Study

NCT06106373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral
  • Hearing Loss, Unilateral

Interventions

DEVICE

iotaSOFT Insertion System

robotic assistive technology for cochlear implant electrode insertion

Sponsors & Collaborators

  • iotaMotion, Inc.

    lead INDUSTRY

Principal Investigators

  • Laura Chenier · iotaMotion, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2024-10-24
Completion
2025-07-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106373 on ClinicalTrials.gov