Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus
Use of a Tethered Capsule Endoscope in Screening for Barrett's Esophagus
研究概览
详细说明
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.
II. Obtain preliminary data for use in designing a subsequent pivotal study of the device.
OUTLINE:
Patients swallow the tethered capsule endoscope (TCE) and undergo endoscopic examination while they are seated on a standard endoscopy gurney. Patients undergo standard of care EGD on the same day.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98109
- Fred Hutch/University of Washington Cancer Consortium
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ability and willingness to provide written informed consent
- Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:设备可行性
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Screening (TCE)
Patients swallow the TCE and undergo endoscopic examination while they are seated on a standard endoscopy gurney.
Patients undergo standard of care EGD on the same day.
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辅助研究
Undergo TCE
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Consistent image quality
大体时间:At the conclusion of TCE exam (day 1)
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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.
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At the conclusion of TCE exam (day 1)
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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
大体时间:At the conclusion of TCE exam (day 1)
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At the conclusion of TCE exam (day 1)
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Incidence of adverse events associated with TCE use
大体时间:Up to 1 year
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Up to 1 year
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合作者和调查者
调查人员
- 首席研究员:Michael Saunders、Fred Hutch/University of Washington Cancer Consortium
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA Incorporated终止
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Mayo ClinicFred Hutchinson Cancer Center完全的
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Massachusetts General Hospital邀请报名
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Lucid Diagnostics, Inc.完全的巴雷特食管 | 食管腺癌 | 无发育不良的 Barrett 食管 | Barretts 食管发育不良美国, 西班牙