Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Number of Polyps With Complete Resection
研究概览
简要总结
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
详细描述
The details of the proposed study are as follows:
-
Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
-
Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
-
Methods:
-
Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
-
If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
-
After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
-
The polyp as well as well as the two biopsies are reviewed by a pathologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, 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
- 是
入选标准
- •Patients 18 years or older
- •Polyps 4-9mm
排除标准
- •Inflammatory bowel disease
- •Polyposis syndromes
研究组 & 干预措施
With EverLift
Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
干预措施: Use of EverLift (Device)
Without EverLift
Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
干预措施: Without use of EverLift (Device)
结局指标
主要结局
Number of Polyps With Complete Resection
时间窗: 2 weeks
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
次要结局
- Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.(During the procedure (up to 10 minutes))
- Number of Patients With Procedural Complications(4 weeks (from procedure through 30 day follow-up))
- Time to Resection(During the procedure)
研究者
Shai Friedland
Professor in Gastroenterology & Hepatology
Stanford University