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The iotaSOFT Insertion System Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577118
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
iotaMotion, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cochlear Implant Device: iotaSOFT Insertion System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The iotaSOFT Insertion System Safety Study
Actual Study Start Date : September 18, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System during cochlear implant surgery [ Time Frame: Day 0 ]
    Proportion 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 :
  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 Outcome Measures:
  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: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577118


Contacts
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Contact: Camille Dunn-Johnson, PhD 319-353-8776 camilledunn@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Camille Dunn-Johnson, PhD         
Sponsors and Collaborators
iotaMotion, Inc.
Investigators
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Principal Investigator: Bruce Gantz, MD University of Iowa
More Information
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Responsible Party: iotaMotion, Inc.
ClinicalTrials.gov Identifier: NCT04577118    
Other Study ID Numbers: iotaSOFT000001
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No