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临床试验/NCT03637712
NCT03637712已完成不适用

Deep-Learning for Automatic Polyp Detection During Colonoscopy

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Adenoma Detection Rate

研究概览

简要总结

The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •People with diminished cognitive capacity.
  • •The subject is pregnant or planning a pregnancy during the study period.
  • •Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
  • •Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
  • •Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
  • •Patients with inflammatory bowel disease
  • •Patients with any polypoid/ulcerated lesion > 20mm concerning for invasive cancer on endoscopy.

研究组 & 干预措施

Screening Colonoscopy

Experimental

Patients undergoing standard screening or surveillance colonoscopy will be included

干预措施: Computer Algorithm (Device)

结局指标

主要结局

Adenoma Detection Rate

时间窗: 1 Day

the proportion of colonoscopic examinations performed that detect one or more polyp

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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