Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 2
- 主要终点
- Number of polyps per patient
研究概览
简要总结
This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.
详细描述
Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.
One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.
Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients referred for colonoscopy age ≥
- •Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.
排除标准
- •History of Inflammatory bowel disease
- •History of Hereditary non polyposis colorectal cancer (HNPCC)
- •Familial adenomatous polyposis syndrome (FAP)
- •Hyperplastic polyposis syndrome
- •Known colonic stricture
研究组 & 干预措施
Standard colonoscopy
A standard colonoscope will be used to complete the procedure
干预措施: Standard colonoscopy (Device)
EndoRings™
An EndoRings™ device will be placed at the distal end of a standard colonoscope
干预措施: EndoRings™ (Device)
结局指标
主要结局
Number of polyps per patient
时间窗: 14 months
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
次要结局
未报告次要终点