Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
研究概览
简要总结
The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
详细描述
96 participants including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a current or prior clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross-sectional images of the esophagus are acquired. Images are analyzed at a later stage.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be a healthy volunteer
- •OR participant must have a suspicion of EoE
- •OR participant must have a prior clinical suspicion of EoE
- •Participant must be older than 14 years of age
- •Participant must be able to give informed consent
排除标准
- •Participants with the inability to swallow pills and capsules.
- •Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- •Participants with prior endoscopic ablation or resection treatment of Barrett's Esophagus (BE)
结局指标
主要结局
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
时间窗: A single 20 minute visit (5-7 minute imaging).
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
时间窗: Questionnaire adminstered directly after the imaging portion has been completed.
After participating in the study, the participants will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
时间窗: A single 20 minute visit (5-7 minute imaging).
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
时间窗: Questionnaire adminstered directly after the imaging portion has been completed.
After participating in the study, the participants will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital