NCT01903629已完成1 期
A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
研究概览
简要总结
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric symptoms and indicated for Upper GI endoscopy
- •Age of 18 years to 70 years
排除标准
- •Patients with impaired bowel movement from ileus or organic digestive diseases
- •Patients with known large and obstructing tumors of the upper GI tract
- •Patients after upper GI surgery or abdominal surgery altering GI anatomy
- •Patients under full anticoagulation
- •Patient in poor general condition
- •Patients using equipment that may be affected by radio transmission
- •Patients using equipment that may be affected by magnetic field
- •Pregnancy or suspected pregnancy
结局指标
主要结局
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
时间窗: 2 days
次要结局
- Examination times of capsule and standard gastroscopy(1 hour)
- Patient acceptance of capsule gastroscopy and standard gastroscopy(3 days)
- Adverse events of both procedures(2 weeks)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital
研究点 (1)
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