iotaSOFT Pediatric Study
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2025
CompletedSeptember 15, 2025
September 1, 2025
2.4 years
October 24, 2023
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety related to adverse events
Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery
30 days following surgery
Study Arms (1)
Pediatric Cochlear Implant Recipient
EXPERIMENTALPediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.
Interventions
robotic assistive technology for cochlear implant electrode insertion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iotaMotion, Inc.lead
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Texas Childrens Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Chenier
iotaMotion, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
October 30, 2023
Study Start
May 17, 2022
Primary Completion
October 24, 2024
Study Completion
July 10, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09