Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.
详细描述
This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 50 to 79 years old
- •Scheduled for screening, surveillance or diagnostic colonoscopy
排除标准
- •Colonic strictures
- •History of bowel surgery
- •Per-rectal bleeding within six weeks
- •Inflammatory bowel disease
- •Pregnancy
研究组 & 干预措施
AmplifEYE colonoscopy
Colonoscopy performed with AmplifEYE equipped
干预措施: AmplifEYE (Device)
Standard colonoscopy
Standard colonoscopy performed
结局指标
主要结局
Adenoma detection rate
时间窗: 1 day
number of patients in whom at least one adenoma could be found
次要结局
- Polyp detection rate(1 day)
- Serrated polyp detection rate(1 day)
- caecal intubation rate(1 day)
- caecal intubation time(1 day)
研究者
Sze Shun Fung
Associate Consultant
Queen Elizabeth Hospital, Hong Kong