Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
NCT ID: NCT07011927
Last Updated: 2025-06-12
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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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2025-06-03
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients scheduled for Cochlear Implantation
The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.
Cochlear Implant
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Modified Implant Procedure
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Interventions
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Cochlear Implant
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Modified Implant Procedure
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Eligibility Criteria
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Inclusion Criteria
* is willing to participate in the study
Exclusion Criteria
* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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J. Thomas Roland, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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24-01768
Identifier Type: -
Identifier Source: org_study_id
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