Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Electrical impedance difference between positive and negative surgical margins
研究概览
简要总结
This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.
详细描述
Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.
The trial will consist of recording EII data from:
- In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
- Resected ex vivo prostate following extraction from the abdomen (in the OR)
- Resected ex vivo prostate when transferred to Pathology, post-RARP
The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of prostate cancer requiring RARP.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age ≥ 18 years old
排除标准
- •Adults with implanted electrical devices such as pacemakers
- •Adults with impaired decision-making capacity
- •Any condition for which, in the opinion of the investigator, contraindicates study participation.
结局指标
主要结局
Electrical impedance difference between positive and negative surgical margins
时间窗: 2023-2025
Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.
次要结局
- Safety of EI sensing in vivo electrical sensing(2023-2025)
- Efficacy of EI sensing in vivo electrical sensing(2023-2025)
研究者
Ryan J. Halter
Investigator and Regulatory Sponsor
Dartmouth-Hitchcock Medical Center