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
干预措施
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
研究组 & 干预措施
magnetic-controlled capsule endoscocpy (MCE)
Experimental
patients were assigned to swallow MCE first, followed by the gastroscopy
干预措施: MCE (Device)
magnetic-controlled capsule endoscocpy (MCE)
Experimental
patients were assigned to swallow MCE first, followed by the gastroscopy
干预措施: Standard gastroscopy (Device)
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)
Loading locations...
相似试验
Unknown
不适用
Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac DiseaseCeliac DiseaseNCT03095573Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico25
已完成
不适用
Can Steerable Capsule Endoscopy Enhance Gastric Emptying?Patients Attending Hospital for Small Bowel EndoscopyNCT02282852Sheffield Teaching Hospitals NHS Foundation Trust24
已完成
不适用
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2Gastrointestinal HemorrhageIntestinal DiseasesNCT01872286Changhai Hospital53
招募中
不适用
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small BowelGastroIntestinal BleedingNCT05949268University Hospital Freiburg1,300
已完成
不适用
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule EndoscopyCrohn's DiseaseNCT01053559Shafran Gastroenterology Center15