Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
研究概览
简要总结
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.
详细描述
The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.
Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.
Participants will have received written information prior to the day of the capsule procedure and participants will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the participant can stop the procedure at any time.
For each of the imaged participants, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.
Participants will be seated and asked to sip water to facilitate swallowing the capsule.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
- •Participants over the age of 18
- •Participants who are capable of giving informed consent
- •Participants who had or will have a standard of care EGD within 9 to 15 months
- •Participants must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
排除标准
- •Participants with prior endoscopic ablation or resection treatment of BE
- •Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
- •Participants with the inability to swallow capsules.
- •Pregnancy, according to participant information
结局指标
主要结局
Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
时间窗: Approximate 25 minutes visit (10 min image acquisition)
An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator - MD, PhD, FACC, FCAP, FNAI
Massachusetts General Hospital