Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

May 7, 2021 updated by: Yanqing Li, Shandong University
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who acccept the magnet controlled capsule endoscopy with the help of "AI-box"will be enrolled.

Description

Inclusion Criteria:

  • patients between 18 and75
  • patients who can sign informed consent

Exclusion Criteria:

  • patients who are unsuitable to accept the check

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The integrity of the magnet controlled capsule endoscopy
Time Frame: 2 months
The performance of the operator developing the MCE in screen the gastric without omissions
2 months
The visibilty of the gastric
Time Frame: 2 months
Evaluating the performance of AI to recognize the visibility of gastric mucosa
2 months
The time of operation in gastric
Time Frame: 2 months
Calculating the time of the magnet controlled capsule endoscapy
2 months

Collaborators and Investigators

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

Sponsor

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)

January 1, 2020

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020SDU-QILU-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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