A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- judgement of normal or abnormal of gastrointestinal tract
研究概览
简要总结
Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. This study was aimed to compare the performance between the frequency-altering AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •obscure gastrointestinal bleeding
- •chronic diarrhea
- •suspected Crohn's disease
- •chronic abdominal pain
- •neoplastic lesions of small bowel
排除标准
- •patients with any contraindication to capsule endoscopy
研究组 & 干预措施
Pillcam SB2 first
patients were assigned to swallow PSB first, followed by the AKE
干预措施: AKE-1 (Device)
Pillcam SB2 first
patients were assigned to swallow PSB first, followed by the AKE
干预措施: Pillcam SB2 (Device)
AKE-1 first
patients were assigned to swallow AKE first, followed by the PSB
干预措施: Pillcam SB2 (Device)
AKE-1 first
patients were assigned to swallow AKE first, followed by the PSB
干预措施: AKE-1 (Device)
结局指标
主要结局
judgement of normal or abnormal of gastrointestinal tract
时间窗: 5 weeks after the examination
If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal.
次要结局
- diagnostic yield(5 weeks after the examination)
- small-bowel transit time(the comparison was completed 5 weeks after the examination)
- total number of images captured(the comparison was completed 5 weeks after the examination)
- total recording time(5 weeks after the examination)
- gastric transit time(the comparison was completed 5 weeks after the examination)
- complete small-bowel examination rate(5 weeks after the examination)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital