Evaluating a new system for cochlear implant surgery in children
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
This study is testing a new tool for cochlear implant surgery in children to see if it makes the procedure safer and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 9 Months to 12 Years |
| Sex | All |
| Sponsor | iotaMotion, Inc. Industry-sponsored |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Trial ID | NCT06106373 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of the iotaSOFT Insertion System, which is designed to assist in the insertion of electrode arrays during cochlear implant surgeries in pediatric patients. It is a prospective, non-randomized, open-label study that will involve children aged 9 months to less than 12 years who are candidates for unilateral or bilateral cochlear implantation. Participants will be monitored for their compliance with follow-up visits to evaluate outcomes related to the use of this innovative insertion system.
Who should consider this trial
Good fit: Ideal candidates are children aged 9 months to less than 12 years who are eligible for cochlear implantation.
Not a fit: Patients with prior cochlear implants, certain cochlear anomalies, or other specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce complications associated with cochlear implant procedures in children.
How similar studies have performed: While this approach is innovative, similar studies evaluating new surgical techniques in cochlear implantation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Iowa City, Iowa and 1 other locations
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Texas Childrens Hospital — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Laura Chenier, AuD
- Email: lchenier@iotamotion.com
- Phone: 442-325-4171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.