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临床试验/NCT05459714
NCT05459714Unknown不适用

A Prospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients

Changhai Hospital3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
3
主要终点
Number of Participants With Complete Observation

研究概览

简要总结

This study is a prospective, multicenter clinical trial. The study is planned to be conducted at a qualified clinical trial center, and 30 subjects are planned to be enrolled to evaluate the feasibility and safety of magnetically controlled capsule endoscopy (MCE) system in the examination of gastric disorders in patients with moderate to severe obesity (BMI ≥ 35 kg/m2).

详细描述

Metabolic surgery, as one of the most important treatments for obesity, has been widely used worldwide. Esophagogastroduodenoscopy (EGD) is mostly used in the perioperative preoperative application of metabolic surgery to improve or exclude preoperative diagnosis, including gastrointestinal tumors, various types of upper GI mucosal lesions, esophagitis, esophageal hiatal hernia, gastrointestinal interstitial tumors, etc. However, EGD is an invasive examination and can cause discomfort without anesthesia, resulting in low patient compliance. In 2013, ANKON took the lead in developing the world's first capsule endoscope system that utilizes precise multi-dimensional rotational movement of a robotic arm and adaptive matching to achieve precise magnetic control, which is convenient for observing specific lesions from an appropriate angle and has been shown to have high diagnostic accuracy for gastric diseases (highly consistent with EGD, with sensitivity and specificity of 90.4% and 95.7%, respectively, and accuracy of 93.4%). It has been clinically proven that MCE is safe and effective in the upper gastrointestinal tract, but there is a lack of clinical systematic studies on its application to moderately and severely obese people.In summary, this exploratory study is designed to preliminarily verify the clinical feasibility and safety of MCE for upper gastrointestinal examination in moderately obese people (BMI ≥ 35 kg/m2).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of obesity: BMI ≥ 35kg/m2;
  • Be scheduled to undergo gastric examination;
  • 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

Number of Participants With Complete Observation

时间窗: 2 weeks

The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus.

次要结局

  • The Total Number of Patients Who Who Had a Diagnosis of Positive Findings(2 weeks)
  • Evaluation of patient satisfaction through questionaires(2 weeks)
  • Gastric Examination Time(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

研究点 (3)

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