Pilot Study to Image the Esophagus Using a SECM Probe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Participants With Tolerability of the Procedure
研究概览
简要总结
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
详细描述
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.
Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •A previous diagnosis of Barrett's Esophagus
- •Patients must be over the age of 18
- •Patient must be able to give informed consent
排除标准
- •Subjects with any history of intestinal strictures
- •OR subjects with a history of prior GI surgery
- •OR subjects with a history of intestinal Crohn's disease.
研究组 & 干预措施
SECM Probe Imaging
SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.
干预措施: SECM Probe (Device)
结局指标
主要结局
Number of Participants With Tolerability of the Procedure
时间窗: During the procedure
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital