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临床试验/NCT03883035
NCT03883035已完成不适用

Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms

Yanqing Li1 个研究点 分布在 1 个国家目标入组 1,060 人开始时间: 2019年3月20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
1,060
试验地点
1
主要终点
detection rate of gastric neoplasms

研究概览

简要总结

The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

详细描述

In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing EGD examination with anaesthesia;
  • patients able to give informed consent.

排除标准

  • patients with the contraindications to EGD examination;
  • patients with a prior EGD examination within 1 year before the trial;
  • patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
  • a history of upper gastrointestinal cancers;
  • allergic to anaesthetic in previous medical history;
  • patients refused to participate in the trial;
  • the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

结局指标

主要结局

detection rate of gastric neoplasms

时间窗: 8 months

detection rate of gastric neoplasms in different groups

次要结局

  • mean inspection completeness(8 months)
  • mean number of gastric neoplasms detected(8 months)
  • mean inspection time(8 months)
  • errors of EAS(8 months)

研究者

发起方
Yanqing Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanqing Li

vice president of Qilu Hospital

Shandong University

研究点 (1)

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