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临床试验/NCT06020859
NCT06020859尚未招募不适用

New MCE System for Detection of Gastric Lesions

Changhai Hospital0 个研究点目标入组 30 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
the degree of gastric mucosal visualization

研究概览

简要总结

Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

详细描述

The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

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
Single (Participant)

入排标准

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

入选标准

  • underwent gastric examination;
  • At least 18 years old;
  • Be able to provide informed consent.

排除标准

  • With swallowing obstruction or disorders;
  • With known or suspected gastrointestinal obstruction, stenosis and fistula;
  • Have no conditions for surgery or refuse to undergo any abdominal surgery;
  • Be allergic to or have other known contraindication or intolerance to the drug used in the study;
  • With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
  • Women during pregnancy;
  • Currently enrolled in another clinical trial of a drug or device;
  • Other conditions determined by the investigator to be inappropriate for enrollment.

结局指标

主要结局

the degree of gastric mucosal visualization

时间窗: 2 weeks

The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.

次要结局

  • Safety Assessment(2 weeks)
  • detection of lesions(2 weeks)
  • The time of gastric examination(2 weeks)
  • Equipment operation evaluation(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuan Liao

Professor

Changhai Hospital

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