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

Capsule Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203264
• Other study ID #: 20190411A
• Status: Recruiting
• Start date: December 16, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2019
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 008621-31161004
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Ding Z, Shi H, Zhang H, Meng L, Fan M, Han C, Zhang K, Ming F, Xie X, Liu H, Liu J, Lin R, Hou X. Gastroenterologist-Level Identification of Small-Bowel Diseases and Normal Variants by Capsule Endoscopy Using a Deep-Learning Model. Gastroenterology. 2019 Oct;157(4):1044-1054.e5. doi: 10.1053/j.gastro.2019.06.025. Epub 2019 Jun 25. — View Citation

Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1. — View Citation

Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20. — View Citation

Wu L, Zhang J, Zhou W, An P, Shen L, Liu J, Jiang X, Huang X, Mu G, Wan X, Lv X, Gao J, Cui N, Hu S, Chen Y, Hu X, Li J, Chen D, Gong D, He X, Ding Q, Zhu X, Li S, Wei X, Li X, Wang X, Zhou J, Zhang M, Yu HG. Randomised controlled trial of WISENSE, a real-time quality improving system for monitoring blind spots during esophagogastroduodenoscopy. Gut. 2019 Dec;68(12):2161-2169. doi: 10.1136/gutjnl-2018-317366. Epub 2019 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The sensitivity of lesions detected by system	up to 2 weeks
Secondary	Delay time	Average preprocessing and displaying times before and after the execution of system	up to 2 weeks
Secondary	Specificity	The specificity of detected by system	up to 2 weeks
Secondary	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
Secondary	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
Secondary	Accuracy of heat map	The rate of the highlighted area indicated in the lesion	up to 2 weeks
Secondary	Lesion detection yield	The ratio of lesions detected by system to all lesions	up to 2 weeks