Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- capsule endoscope's responsiveness to the attitude controller
研究概览
简要总结
The aim of this study is to evaluate the responsiveness of the capsule endoscope to the attitude controller and to investigate its active locomotion performance within the small bowel.
详细描述
During the standard air insufflation or water infusion phases of double-balloon enteroscopy, researchers will use a handheld controller to try to steer the capsule. At the same time, the real-time imaging from both the enteroscope and the capsule will be simultaneously monitored to assess the capsule's active movement and its responsiveness to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo enteroscopy.
排除标准
- •Patients with severe dysfunction of vital organs (e.g., heart, lungs). Patients with small bowel obstruction precluding adequate bowel preparation. Patients with a history of multiple abdominal surgeries. Patients with implanted devices such as cardiac pacemakers or metal implants. Patients with other high-risk conditions or lesions (e.g., moderate-to-severe esophagogastric varices, massive ascites).
- •Patients who are pregnant or lactating. Patients unable or unwilling to provide informed consent.
结局指标
主要结局
capsule endoscope's responsiveness to the attitude controller
时间窗: During performing double-balloon enteroscope
Excellent: The magnetically controlled capsule endoscope can precisely follow the attitude controller to move to the target area. Moderate: The magnetically controlled capsule endoscope can follow the attitude controller's movement, but cannot be accurately guided to the target area. Poor: There are signs of magnetic attraction, but the capsule does not follow the movement of the attitude controller.
次要结局
未报告次要终点
研究者
Xiuli Zuo
Director of Gastroenterology Department
Qilu Hospital of Shandong University