Real-Time Identification System of Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence

December 16, 2019 updated by: Zhuan Liao, Changhai Hospital

Real-Time Identification of Gastric Lesions and Anatomical Landmarks During Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence

The aim of this study is to evaluate the performance of real-time auxiliary system based on artificial intelligence algorithm in lesion detection and quality control in magnetically controlled capsule endoscopy.

Study Overview

Detailed Description

Magnetically controlled capsule endoscopy (MCE) has been used in clinical practice for gastric examination, with high sensitivity and specificity of 90.4% and 94.7%, respectively.

Therefore, a real-time auxiliary system based on convolutional neural network deep learning framework was developed to assist clinicians to improve the quality in MCE examinations.

Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center were prospectively enrolled. After passage through the esophagus, physician will finish the gastric examination under magnetic steering with the real-time auxiliary system. Professional operators guarantee the integrity of the examination and the diagnostic results of professional endoscopist was used as the gold standard. The system diagnosis results was recorded at the same time. The sensitivity, delay time, specificity of lesions and anatomical landmarks will be analyzed.

Study Type

Observational

Enrollment (Anticipated)

50

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 Locations

      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Sub-Investigator:
          • Jun Pan
        • Contact:
        • Sub-Investigator:
          • Ji Xia

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients undergoing magnetically controlled capsule endoscopy examination

Description

Inclusion Criteria:

  • With or without gastrointestinal complaints
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel
  • Signed the informed consents before joining this study

Exclusion Criteria:

  • Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
  • Refused abdominal surgery to take out the capsule in case of capsule retention
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: up to 2 weeks
The sensitivity of lesions detected by system
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay time
Time Frame: up to 2 weeks
Average preprocessing and displaying times before and after the execution of system
up to 2 weeks
Specificity
Time Frame: up to 2 weeks
The specificity of detected by system
up to 2 weeks
Accuracy of anatomic landmarks identification
Time Frame: up to 2 weeks
Accuracy of anatomic landmarks ( cardia, fundus, body, lesser curvature, greater curvature, angle, antrum and pylorus) identified by real-time identification system
up to 2 weeks
Completeness of real-time observation with assistance
Time Frame: up to 2 weeks
Whether the clinician observed all anatomic landmarks of stomach (cardia, fundus, body, angulus, antrum and pylorus).
up to 2 weeks
Accuracy of heat map
Time Frame: up to 2 weeks
The rate of the highlighted area indicated in the lesion
up to 2 weeks
Lesion detection yield
Time Frame: up to 2 weeks
The ratio of lesions detected by system to all lesions
up to 2 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Zhuan Liao, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 16, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 20190411A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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