Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Median Tolerability Score on 10-point Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.
详细描述
All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.
Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.
- •Able and willing to give informed consent.
排除标准
- •Patients known to be intolerant to endoscopy.
- •Patients with frequent epistaxis.
- •Patients not clinically fit for endoscopy as judged by their care team.
- •Pregnant women.
- •Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)
- •Use of anticoagulants or antiplatelets.
结局指标
主要结局
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
时间窗: Within 48 hours
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
次要结局
- Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy(Two weeks)
研究者
Prasad G. Iyer
Associate Professor of Medicine
Mayo Clinic
