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iotaSOFT Pediatric Study

Sponsor
iotaMotion, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06106373
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
24.5
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iotaSOFT Insertion System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

Device: iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion

Outcome Measures

Primary Outcome Measures

  1. Safety related to adverse events [30 days following surgery]

    Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Months to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Iowa City Iowa United States 52242

Sponsors and Collaborators

  • iotaMotion, Inc.

Investigators

  • Study Director: Laura Chenier, iotaMotion, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iotaMotion, Inc.
ClinicalTrials.gov Identifier:
NCT06106373
Other Study ID Numbers:
  • iotaSOFT000002
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Unilateral

Study Results

No Results Posted as of Oct 30, 2023