NCT03685903Unknown1 期
Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
Capso Vision, Inc.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The ability to detect and visualize the duodenal papilla
研究概览
简要总结
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Males or females at least 18 years of age.
- •Provided written HIPAA Informed Consent in the IRB approved language.
- •Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
排除标准
- •Patients with existing biliary stent will be excluded
- •EUS/ERCP exclusion criteria: per medical practice, including:
- •Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
- •Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
- •Capsule Endoscopy (CE) exclusion criteria:
- •CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
- •Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
- •Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
结局指标
主要结局
The ability to detect and visualize the duodenal papilla
时间窗: during capsule endoscopy procedure
Rate of duodenal papilla detection
次要结局
未报告次要终点
研究者
研究点 (2)
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