The iotaSOFT Insertion System Safety Study

Cochlear Implant Clinical Trial

Official title:

The iotaSOFT Insertion System Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577118
• Other study ID #: iotaSOFT000001
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: April 2, 2021

Study information

• Verified date: February 2024
• Source: iotaMotion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
iotaMotion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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