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临床试验/NCT04195646
NCT04195646已完成不适用

Computer Aided Detection of Polyps During Colonoscopy Procedures

EndoVigilant Inc4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
4
主要终点
Adenomas Per Colonoscopy

研究概览

简要总结

The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.

详细描述

The details of the proposed study are as follows:

  1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor. The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen.
  2. The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor.
  3. The endoscopist will primarily rely on the second monitor (augmented with annotation from EndoVigilant ColonCAD software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient presenting for routine colonoscopy for screening and/or surveillance purposes
  • Ability to provide written, informed consent and understand the responsibilities of study participation

排除标准

  • Patients with diminished cognitive capacity
  • Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
  • Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)

结局指标

主要结局

Adenomas Per Colonoscopy

时间窗: 1 hour

Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level.

次要结局

未报告次要终点

研究者

发起方
EndoVigilant Inc
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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