Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Identification of cause of bleeding on upper endoscopy
研究概览
简要总结
Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.
A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.
详细描述
STUDY DESIGN:
This is a randomized double blind clinical trial of the BioVac suction device versus standard endoscopy suction for UGIB. The study will be performed at London Health Sciences Center Victoria Campus and University Campus with an anticipated recruitment period of 2.5 years.
STUDY POPULATION:
All patients over the age of 18 admitted to hospital with a diagnosis of UGIB will be considered for recruitment. Patients already admitted to hospital with another diagnosis who develop UGIB will also be included.
INTERVENTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identification of cause of bleeding on upper endoscopy
时间窗: Once at the time of endoscopy
The cause of bleeding will be classified by location (esophagus, stomach, duodenum) and etiology (inflammation, ulcer, mass, varices, angioectasia, Dieulafoy, other).
次要结局
- Application of any endoscopic therapy(Once at the time of endoscopy)
- Rebleeding(Measured once 7 days after endoscopy)
- Transfusion requirement(Measured once 7 days after endoscopy)
- Length of hospital stay(Measured once 30 days after endoscopy)
- Need for interventional radiology or surgery(Measured once 30 days after endoscopy)
- 30 day mortality(Measured once 30 days after endoscopy)
- Need for repeat EGD within 72 hours(Measured once 7 days after endoscopy)
- Procedure duration(Once at the time of endoscopy video review)
研究者
Michael Sai Lai Sey, MD
Principal Investigator
Lawson Health Research Institute