The iotaSOFT Insertion System Safety Study

Not Applicable

Completed

• Conditions: Cochlear Implant
• Interventions: Device: iotaSOFT Insertion System

• Registration Number: NCT04577118
• Lead Sponsor: iotaMotion, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2020-09-18
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02
• Status Verified: 2024-02
• Results First Submitted: 2024-02-01
• Results First Submitted QC: 2024-02-28
• Results First Posted: 2024-03-27
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iotaSOFT Insertion System	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
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.	Day 0	The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States