SB3 Battery Life Observational Study
Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study
Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.
While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended.
This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
British Columbia
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Vancouver、British Columbia、加拿大、V6Z 2K5
- St. Paul's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female age 19 or greater who are referred for small bowel capsule endoscopy
- Willing and able to provide written informed consent
Exclusion Criteria:
- Unwillingness or inability to swallow pill
- Known or suspected obstruction or bowel stricture
- Endoscopic placement of capsule camera
- Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Completion Rate (Rate at Which Small Bowel is Completely Examined)
大体时间:0.1 - 12 hours
|
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
|
0.1 - 12 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Diagnostic Yield
大体时间:0.1 - 12 hours
|
rate at which a pathological finding is identified on capsule endoscopy
|
0.1 - 12 hours
|
Gastric Transit Time
大体时间:0.1 - 12 hours
|
time it takes for capsule camera to traverse the stomach
|
0.1 - 12 hours
|
Small Bowel Transit Time
大体时间:0.1 - 12 hours
|
times it takes for capsule camera to traverse the entire small bowel.
|
0.1 - 12 hours
|
合作者和调查者
调查人员
- 首席研究员:Robert Enns, MD、University of British Columbia
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- H14-03253
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.