Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
研究概览
简要总结
The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).
详细描述
A total of 130 participants scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.
Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 must be undergoing an EGD.
- •Patients must be over the age of
- •Patients must be able to give informed consent.
排除标准
- •Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
- •OR patients with a history of hemostasis disorders.
- •OR patients with esophageal strictures.
结局指标
主要结局
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
时间窗: It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
次要结局
- Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE(It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes)
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital