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

February 8, 2022 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yanqing Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: AI-box
Automatic quality-control system（AI-box）could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.
No Intervention: Participates being subjected to capsule endoscopy
In this group ,Participates will be subjected to magnet controlled capsule endoscopy without AI-box assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Shandong Provincial Hospital
Binzhou Medical University
Ancon Technologies Ltd

Investigators

  • Study Chair: Yanqing Li, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-SDU-QILU-087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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