Use of a Tethered Capsule Endoscope in Screening for Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Consistent image quality
研究概览
简要总结
This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate image quality and usability of the tethered capsule endoscope after repeated clinical use and reprocessing.
II. Evaluate safety issues associated with the use of the device for this subject population - was there any noticeable difference from prior study of subjects at high risk of Barrett's esophagus using the same device, but without reprocessing.
SECONDARY OBJECTIVES;
I. Study other specified device characteristics or device application considerations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Ability and willingness to provide written informed consent
- •Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus
排除标准
- •Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
- •Symptoms of dysphagia
- •Suspicion or known history of gastrointestinal obstruction
- •History of prior surgery on the oropharynx, neck, esophagus, or stomach
- •Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness
- •Currently taking anticoagulant medications or clopidogrel
- •Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
- •Inability to abstain from taking anything by mouth for at least 6 hours
- •Currently pregnant
- •Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure
结局指标
主要结局
Consistent image quality
时间窗: At the conclusion of TCE exam (day 1)
Consistent image quality defined as no significant degradation of lateral spatial resolution \[line pairs per mm\] and axial depth of focus \[mm\], maximum field of view \[degrees cone angle\], and color fidelity \[qualitatively matches color chart\] when measured after use in the clinic using color and resolution test targets and a test chamber to measure field of view. The standard care EGD will be digitally recorded to allow for review and comparison to the TCE procedure by a blinded, expert endoscopist.
Consistent usability defined as no significant change to the tolerance rating given by the patient by survey, and ease of use by the physician by survey, and time for completing the examination
时间窗: At the conclusion of TCE exam (day 1)
Incidence of adverse events associated with TCE use
时间窗: Up to 1 year
次要结局
未报告次要终点