Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery (AIMBOT)

April 28, 2025 updated by: iotaMotion, Inc.
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cochlear implant candidate in one or two ears per current FDA indications
  2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
  3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
  4. 18 years of age or older at the time of enrollment
  5. Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.

4. History of temporal bone fracture that involves the cochlea/internal auditory canal.

5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).

6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.

7. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.

8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.

9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.

10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Use of the iotaSOFT Insertion System and AIM based on Standard of Care
Device: iotaSOFT Insertion System with AIM Control
iotaSOFT Insertion System with AIM using standard of care insertion techniques
Experimental: Experimental
Use of iotaSOFT Insertion System with AIM experimental device
Device: iotaSOFT Insertion System with AIM
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Feasibility
Time Frame: Procedure Day 0
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
Procedure Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iotaMotion, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAR2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be determined based on the results of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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