COMPLETED

iotaSOFT Pediatric Study

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

Quick Facts

Study Start:2022-05-17

Study Completion:2025-07-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06106373

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.

Ages Eligible for Study:9 Months to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Laura Chenier

STUDY_DIRECTOR

iotaMotion, Inc.

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

United States

Texas Childrens Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: iotaMotion, Inc.

Laura Chenier, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2022-05-17

Study Completion Date2025-07-10

Study Record Updates

Study Start Date2022-05-17

Study Completion Date2025-07-10

Terms related to this study

Additional Relevant MeSH Terms

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