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Completed

NCT Number: NCT04954677

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Box

Other

Automatic quality-control system(AI-box)could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.

Primary outcomes

  1. Mean inspection completeness

    Time frame: 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.

Secondary outcomes

  1. Cleanliness judgement consistency between expert and AI-box

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Ancon Technologies Ltd
  • Binzhou Medical University
  • Shandong Provincial Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2021
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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