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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106373
Other study ID # iotaSOFT000002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 17, 2022
Est. completion date June 1, 2024

Study information

Verified date February 2024
Source iotaMotion, Inc.
Contact Laura Chenier, AuD
Phone 442-325-4171
Email lchenier@iotamotion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 12 Years
Eligibility 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 Design


Intervention

Device:
iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion

Locations

Country Name City State
United States Texas Childrens Hospital Houston Texas
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
iotaMotion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety related to adverse events Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery 30 days following surgery
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