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The iotaSOFT Insertion System Safety Study

NCT04577118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-04-30

Study results available
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Summary

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

Conditions

  • Cochlear Implant

Interventions

DEVICE

iotaSOFT Insertion System

Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.

Sponsors & Collaborators

  • iotaMotion, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Gantz, MD · University of Iowa

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2021-04-02
Completion
2021-04-02
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 NCT04577118 on ClinicalTrials.gov