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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Capsule Endoscopy

Intervention / Treatment
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* Diagnostic Test: Real-time artificial intelligence identification system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Real-time artificial intelligence identification system|The patients swallowed the MCE with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. The magnetic steering time for passing through the pylorus was not allowed more than 15 min. The real-time auxiliary system implemented real-time processing for the output image of MCE 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.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence, magnetically controlled capsule endoscopy