NCT06748911招募中不适用
Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Detection of Columnar lined epithelium in the esophagus
研究概览
简要总结
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
- •All Patients:
- •o Have had an endoscopy within 1 year of baseline enrollment
- •Patients with Barrett's Esophagus:
- •Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or
- •Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines
排除标准
- •Inability to comprehend or read the consent form
- •Have an oropharynx, esophageal, or gastro-esophageal tumor
- •Ongoing symptoms of dysphagia
- •Presence of active clinically significant stricture
- •History of stricture requiring dilation
- •Presence of pacemaker or implanted cardiac defibrillator
- •History of esophageal surgery with the exception of fundoplication
- •Pregnancy
- •History of surgery or obstructive process of the small bowel
- •BMI > 38
研究组 & 干预措施
Long Segment Barrett's Esophagus (LSBE)
Experimental
Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE)
干预措施: NaviCam Detachable String Capsule (Device)
Short Segment Barrett's Esophagus (SSBE)
Experimental
Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE)
干预措施: NaviCam Detachable String Capsule (Device)
Gastro Esophageal Reflux Disease
Experimental
Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening
干预措施: NaviCam Detachable String Capsule (Device)
结局指标
主要结局
Detection of Columnar lined epithelium in the esophagus
时间窗: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..
Detection of Columnar lined epithelium in the esophagus
次要结局
- Visual Analogue Scale (VAS)(30 minutes post-procedure)
- Spielberger State-Trait Anxiety Inventory (STAI-6)(Baseline, 30 minutes post-procedure)
- Impact of Events Scale (IES)(Baseline, 7 days post-procedure)
研究者
研究点 (2)
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