Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Feasibility and Sensitivity of OFDI Imaging in the Colon
研究概览
简要总结
The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.
详细描述
The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Patients undergoing a screening colonoscopy
- •Patients must be over the age of 18
- •Patient must be able to give informed consent
排除标准
- •Patients with hemostasis disorders
- •Patients taking any anti-coagulants such as Coumadin or Plavix,
研究组 & 干预措施
OFDI imaging
OFDI imaging
干预措施: MGH Optical Frequency Domain Imaging (OFDI) System (Device)
结局指标
主要结局
Feasibility and Sensitivity of OFDI Imaging in the Colon
时间窗: During the OFDI imaging session which should take an average of 5 mintues
OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital