The iotaSOFT Insertion System Safety Study

NCT04577118 | Completed Results FDA Device

• 1 other identifier: iotaSOFT000001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (3)

• Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)

  Day 0

• Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure

  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.

  1 month

Study Arms (1)

iotaSOFT Insertion System

OTHER

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

Interventions

iotaSOFT Insertion System DEVICE

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.

iotaSOFT Insertion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• iotaMotion, Inc.: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Laura Chenier
• Organization: iotaMotion, Inc

lchenier@iotamotion.com

442-325-4171

Study Officials

• Bruce Gantz, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 6, 2020
• Study Start: September 18, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 30, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)