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临床试验/NCT04654247
NCT04654247已完成不适用

A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年4月20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
17
试验地点
1
主要终点
Gastric precancerous detection rate

研究概览

简要总结

We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (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

入选标准

  • Endoscopist:
  • Endoscopist with more than one year experience in gastrointestinal mirror operation;
  • Willing to further improve endoscopic quality through Endo.Adm feedback;
  • Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.

排除标准

  • Endoscopist:
  • Have participated in other clinical trials;
  • Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
  • Endoscopist who were either not present for both parts (phase1 and phase2) of the study.
  • Colonoscopy:
  • Polyposis syndromes
  • Lumen obstruction
  • History of colorectal surgery
  • History of colorectal surgery
  • Gastroscopy:
  • Obstruction
  • History of gastric surgery

结局指标

主要结局

Gastric precancerous detection rate

时间窗: 3 Months

GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.

Adenoma detection rate

时间窗: 3 Months

ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.

次要结局

  • Adcanced ADR(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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