Characterizing In Vivo Oral Lesion Impedances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Differences in Electrical Impedance
研究概览
简要总结
The primary objective of this study is to demonstrate a significant difference in electrical impedance between normal, benign, premalignant, and malignant oral lesions using a custom device. The secondary study objective is to create a database of in vivo electrical impedance spectra and images of oral lesions. This will be achieved by collecting Electrical Impedance sensing data and images from two cohorts of patients: Cohort I will consist of 200 patients undergoing oral lesion biopsies and Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.
详细描述
For this study, a novel small field-of-view EII probe will be used for recording impedances from oral lesions. The device is comprised of gold-plated electrodes with analog electronics located in the probe's tip, to minimize cable lengths and maximize the signal-to-noise ratio. A pressure sensor is embedded within the probe to reduce variability in the amount of pressure used when the probe is applied to soft tissue. The bioimpedance-sensing probe is designed to the following specifications in order to accurately assess oral lesions:
- measurement precision ~85 dB,
- accuracy >99%,
- bandwidth extending to 1 MHz, and
- multi-frequency sample rate of >10 impedance spectra per second.
Similar to other EII systems the team has developed and deployed in vivo, the system complies with International Electrotechnical Commission (IEC) requirements for safety and essential performance of medical electrical equipment (IEC 60601-1).
There are no known probes cleared by the FDA for this application.
The study is not being conducted in order to evaluate the EII probe's safety or effectiveness in human subjects, nor to test the device for marketing or promotion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Differences in Electrical Impedance
时间窗: Participants are on study only the day of the procedure.
This study will use a custom device to measure differences in electrical impedance between normal, benign, premalignant, and malignant oral lesions.
次要结局
- Images and Measurements Database Creation(Participants are on study only the day of the procedure.)
研究者
Ryan J. Halter
Investigator and Regulatory Sponsor
Dartmouth-Hitchcock Medical Center