- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320251
Tissue Growth Characterization for Cochlear Implant Users
It is known from post-mortem histological studies that a significant portion of individuals who undergo cochlear implantation (CI) have scar tissue form around the implanted electrode array over time. This scar tissue affects the electrical performance of the cochlear implant, affecting how the implant stimulates the auditory nerve. It is possible that if this scar tissue was detected, the implant programming could be adjusted to account for the changing tissue properties. As part of another study, a computational modeling approach for patient-customized simulation of cochlear implant stimulation is being developed. The simulation approach uses as input CT images and electrophysiological measurements from the cochlear implant device to simulate stimulation by the cochlear implant. These computational simulation models also provide a way to estimate tissue growth around the array. Tissue growth estimates are optimized in the computational model so that electrophysiological metrics simulated by the model match measurements acquired from the patient's implant. In this study, the aim is to collect data necessary to validate these model predictions.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female 18 years of age and above undergoing revision cochlear implant surgery.
Exclusion Criteria:
- Age < 18 years or not undergoing revision cochlear implant surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
The single observational cohort
|
Observation during routine cochlear implant revision surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue growth
Time Frame: intraoperative
|
Number of individuals with observation of tissue growth around the array by cochlear implant revision surgeon
|
intraoperative
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jack Noble, PhD, Vanderbilt University
- Study Chair: Robert Labadie, MD,PhD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 192257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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