Tissue Growth Characterization for Cochlear Implant Users
NCT ID: NCT04320251
Last Updated: 2025-07-17
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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ENROLLING_BY_INVITATION
NA
24 participants
INTERVENTIONAL
2026-06-15
2027-01-09
Brief Summary
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While the existence of tissue growth around the implanted array is not typically known for most patients, a subset of cochlear implant recipients need to undergo revision surgery when a device failure or poor placement is suspected. For these individuals, the existence of tissue growth around the array in the base of the cochlea can be visualized in the operating room by the surgeon. Individuals will be recruited who are undergoing CI revision surgery at Vanderbilt University Medical Center to participate in this study. In surgery, the presence of scar tissue growth will be evaluated by visual confirmation by the surgeon.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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1
The single observational cohort
cochlear implant revision surgery
Observation during routine cochlear implant revision surgery
Interventions
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cochlear implant revision surgery
Observation during routine cochlear implant revision surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Jack Noble
Assistant Professor, Dept. Electrical Engineering & Computer Science
Principal Investigators
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Jack Noble, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Robert Labadie, MD,PhD
Role: STUDY_CHAIR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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192257
Identifier Type: -
Identifier Source: org_study_id
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