iotaSOFT Pediatric Study

Hearing Loss, Sensorineural Clinical Trial

Official title:

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106373
• Other study ID #: iotaSOFT000002
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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