The iotaSOFT Insertion System Safety Study

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

Study Overview

• Status: Completed
• Conditions: Cochlear Implant
• Intervention / Treatment: Device: iotaSOFT Insertion System

Detailed Description

This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Candidate for cochlear implantation per indications
• Age 18 years or older

Key Exclusion Criteria:

• Prior cochlear implantation in ear to be treated
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
• Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
• Deafness due to lesions of the acoustic nerve or central auditory pathway
• Diagnosis of auditory neuropathy
• Active middle ear infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: iotaSOFT Insertion System; The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery.	Device: iotaSOFT Insertion System; Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery	Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended.	The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)	The duration of time it takes for electrode array insertion will be measured	Day 0
Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure	Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.	Day 0
Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event.	Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry.	1 month

Collaborators and Investigators

• Sponsor: iotaMotion, Inc.
• Investigators: Principal Investigator: Bruce Gantz, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: iotaSOFT000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No