Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
研究概览
简要总结
The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.
详细描述
The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and participants with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates
- •18 years or older
- •Able to give informed consent
- •Participants must have no food for 1 hour before the procedure
排除标准
- •Participants older than 75 years.
- •Participants with current symptoms of dysphagia
- •Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
- •Pregnancy
- •Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.
结局指标
主要结局
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
时间窗: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey
The study team will ask the participant about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable. The title of the scale is Subject Tolerability Questionnaire.
Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.
时间窗: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI
Massachusetts General Hospital