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

N

Naval Military Medical University

Status

Unknown

Conditions

Capsule Endoscopy

Treatments

Diagnostic Test: Real-time artificial intelligence identification system

Study type

Observational

Funder types

Other

Identifiers

NCT04203264
20190411A

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Zhuan Liao

Data sourced from clinicaltrials.gov

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