- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106373
iotaSOFT Pediatric Study
February 28, 2024 updated by: iotaMotion, Inc.
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Chenier, AuD
- Phone Number: 442-325-4171
- Email: lchenier@iotamotion.com
Study Contact Backup
- Name: Wade Colburn
- Email: wcolburn@iotamotion.com
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
-
Principal Investigator:
- Bruce Gantz, MD
-
Contact:
- Camille Dunn, PhD
- Phone Number: 319-356-2421
-
-
Texas
-
Houston, Texas, United States, 77030
- Not yet recruiting
- Texas Childrens Hospital
-
Contact:
- Nathan Lindquist, MD
- Email: nathan.lindquist@bcm.edu
-
Contact:
- Paulina Powell
- Email: powell@texaschildrens.org
-
Principal Investigator:
- Nathan Lindquist, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pediatric Cochlear Implant Recipient
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.
|
robotic assistive technology for cochlear implant electrode insertion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety related to adverse events
Time Frame: 30 days following surgery
|
Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery
|
30 days following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Laura Chenier, 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 Major Dates
Study Start (Actual)
May 17, 2022
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Estimated)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iotaSOFT000002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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