Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
NCT ID: NCT06664710
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-01-17
2025-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Control
Use of the iotaSOFT Insertion System and AIM based on Standard of Care
iotaSOFT Insertion System with AIM Control
iotaSOFT Insertion System with AIM using standard of care insertion techniques
Experimental
Use of iotaSOFT Insertion System with AIM experimental device
iotaSOFT Insertion System with AIM
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
Interventions
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iotaSOFT Insertion System with AIM
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
iotaSOFT Insertion System with AIM Control
iotaSOFT Insertion System with AIM using standard of care insertion techniques
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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iotaMotion, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Iowa
Iowa City, Iowa, United States
Countries
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Central Contacts
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Other Identifiers
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IAR2401
Identifier Type: -
Identifier Source: org_study_id
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