Tissue Growth Characterization for Cochlear Implant Users

NCT ID: NCT04320251

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-15

Study Completion Date

2027-01-09

Brief Summary

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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.

Detailed Description

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Conditions

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Cochlear Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

The single observational cohort

Group Type EXPERIMENTAL

cochlear implant revision surgery

Intervention Type PROCEDURE

Observation during routine cochlear implant revision surgery

Interventions

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cochlear implant revision surgery

Observation during routine cochlear implant revision surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jack Noble

Assistant Professor, Dept. Electrical Engineering & Computer Science

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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192257

Identifier Type: -

Identifier Source: org_study_id

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