跳至主要内容
临床试验/NCT05963724
NCT05963724已完成不适用

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

Riverside University Health System Medical Center2 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
2
主要终点
Adenoma Detection Rate

研究概览

简要总结

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

详细描述

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing colonoscopy at RUHS
  • Age > 45 years
  • No contraindications to colonoscopy

排除标准

  • Prior history of subtotal colectomy

结局指标

主要结局

Adenoma Detection Rate

时间窗: 1 year

次要结局

  • False Neoplasia Rate(1 year)
  • Sessile Serrated Lesions Per Colon(1 year)
  • Sessile Serrated Lesion Detection Rate(1 year)
  • Withdrawal Time(1 year)
  • Adenomas Per Colon(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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