Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy for Screening of Barrett's Esophagus: A Prospective Tandem Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy
研究概览
简要总结
This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.
详细描述
This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study
Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.
The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age: ≥ 18 years
- •Patients with BE length ≥ 1cm undergoing upper endoscopy
- •Willingness to undergo both unsedated, capsule endoscopy and conventional EGD
- •Ability to provide written, informed consent and understand the responsibilities of trial participation
排除标准
- •Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- •Pregnant or planning a pregnancy during the study period
- •Dysphagia
- •Known esophageal diverticulum or stricture
- •Swallowing disorder
- •Known luminal, gastrointestinal stricture
- •History of esophageal, gastric surgery
- •Esophageal or GI motility disorder
- •Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- •Known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- •Subjects with cardiac pacemakers or other implanted electromedical devices.
- •Anticipated magnetic resonance imaging within 1 week of capsule ingestion
结局指标
主要结局
The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy
时间窗: 1 year
The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.
次要结局
- Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy(1 year)