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临床试验/NCT04320251
NCT04320251Enrolling By Invitation不适用

Tissue Growth Characterization for Cochlear Implant Users

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
24
试验地点
2
主要终点
Tissue growth

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female 18 years of age and above undergoing revision cochlear implant surgery.

排除标准

  • Age < 18 years or not undergoing revision cochlear implant surgery.

结局指标

主要结局

Tissue growth

时间窗: intraoperative

Number of individuals with observation of tissue growth around the array by cochlear implant revision surgeon

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jack Noble

Assistant Professor, Dept. Electrical Engineering & Computer Science

Vanderbilt University

研究点 (2)

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