NCT02885987撤回不适用
Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
研究概览
简要总结
The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.
排除标准
- •Any pregnant patient
- •Patient's that are unable to provide consent for themselves
- •Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)
- •Any patient undergoing surveillance (prior history of polyps or colorectal cancer)
- •Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member <65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)
- •Prior history of any cancer
- •Current or past immunosuppression (due to either infection or medications)
- •Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure
- •Colonic strictures
- •suspected intestinal obstruction or colonic pseudo-obstruction
- •history of colon resection
- •active infection
- •active inflammation (including diverticulitis)
结局指标
主要结局
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
时间窗: 1 week
ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed.
次要结局
- ADR will be differentiated according to morphology(1 week)
- Sedative Medications used(1 hour)
- ADR will be differentiated according to final pathology(1 week)
- Advanced ADR(1 week)
- ADR-plus(1 week)
- ADR will be differentiated according to location(1 week)
- APP (adenomas per positive participant)(1 week)
- Quality metrics: time of colonoscopy(1 hour)
- Quality metrics: prep quality(1 hour)
- Mean total number of polyps detected(1 week)
- APC (adenomas per colonoscopy)(1 week)
研究者
Alexander Jahng, MD
Assistant Professor
Loma Linda University
研究点 (2)
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