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Completed

NCT Number: NCT04577118

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.

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Key information

Conditions

Cochlear Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery

    Time frame: 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 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.

    Time frame: 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.

Other outcomes

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

    Time frame: Day 0

    The duration of time it takes for electrode array insertion will be measured

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

    Time frame: Day 0

    Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.

  3. 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.

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

iotaMotion, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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