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A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy

2022年2月8日 更新者:Yanqing Li、Shandong University

A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.

With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.

研究概览

地位

招聘中

干预/治疗

详细说明

The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.

研究类型

介入性

注册 (预期的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Shandong
      • Jinan、Shandong、中国
        • 招聘中
        • Qilu Hospital of Shandong University
        • 接触:
          • Yanqing Li

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.

Exclusion Criteria:

  • People who are allergic to the ingredients prepared in the stomach before examination;
  • Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
  • Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
  • Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
  • Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
  • Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);
  • A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;
  • Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;
  • Planned MRI examination before capsule endoscopy discharge;
  • Pregnant women;
  • Patients with deglutition disorders or gastric emptizing disorders.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Participates being subjected to capsule endoscopy (AI-box assistant)
In this group ,Participates will be subjected to magnet controlled capsule endoscopy with AI-box assistant.
Automatic quality-control system(AI-box)could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.
无干预:Participates being subjected to capsule endoscopy
In this group ,Participates will be subjected to magnet controlled capsule endoscopy without AI-box assistant.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean inspection completeness
大体时间:4 months
After the inspection,investigators will review the whole process of inspection and record the sites observed as well as unobserved sites,then calculate the inspection completeness(number of observed sites in each patient/10)besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.
4 months

次要结果测量

结果测量
措施说明
大体时间
Cleanliness judgement consistency between expert and AI-box
大体时间:4 months
After the inspection,investigators will review the whole process of inspection and make a judgement of cleanliness of different sites of gastric then compared with the cleanliness judgement of AI-box. So at last investigators will calculate the accuracy of the AI result.
4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Yanqing Li, PhD、Qilu Hospital of Shandong University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月27日

初级完成 (预期的)

2022年4月1日

研究完成 (预期的)

2022年5月1日

研究注册日期

首次提交

2021年6月18日

首先提交符合 QC 标准的

2021年7月1日

首次发布 (实际的)

2021年7月8日

研究记录更新

最后更新发布 (实际的)

2022年2月10日

上次提交的符合 QC 标准的更新

2022年2月8日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2021-SDU-QILU-087

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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