Capsule EndoscopyNCT04203264
Real-Time Identification System of Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence
An observational study of Capsule Endoscopy, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsule Endoscopy
- What is being tested?
- Real-time artificial intelligence identification system
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients undergoing magnetically controlled capsule endoscopy examination
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Zhuan Liao, 008621-31161004, liaozhuan@smmu.edu.cn
Ji Xia
About this study
Official title: 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.
Read the 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.
- Conditions
- Capsule Endoscopy
- Being tested
- Real-time artificial intelligence identification system
- Keywords
- artificial intelligence, magnetically controlled capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time artificial intelligence identification systemDiagnostic test
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 being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The sensitivity of lesions detected by system
Measured: up to 2 weeks
Secondary outcomes (6)
Delay time
Average preprocessing and displaying times before and after the execution of system
Measured: up to 2 weeks
Specificity
The specificity of detected by system
Measured: 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
Measured: 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).
Measured: up to 2 weeks
Accuracy of heat map
The rate of the highlighted area indicated in the lesion
Measured: up to 2 weeks
Lesion detection yield
The ratio of lesions detected by system to all lesions
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start16 Dec 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203264
- Sponsor's protocol ID
- 20190411A
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23687601Liao 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.
PubMed 27211503Wu 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.
PubMed 30858305Ding 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.
PubMed 31251929
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Identification of Gastric Lesions and Anatomical Landmarks During Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04203264
- Acronym / sponsor ID
- 20190411A
- Conditions
- Capsule Endoscopy
- Keywords
- artificial intelligence, magnetically controlled capsule endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 16 Dec 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients undergoing magnetically controlled capsule endoscopy examination
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time artificial intelligence identification systemThe 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. | Diagnostic test | – |
Primary outcome
Sensitivity
Time frame: up to 2 weeks
The sensitivity of lesions detected by system
6 secondary outcomes
Delay time
Time frame: up to 2 weeks
Specificity
Time frame: up to 2 weeks
Accuracy of anatomic landmarks identification
Time frame: up to 2 weeks
Completeness of real-time observation with assistance
Time frame: up to 2 weeks
Accuracy of heat map
Time frame: up to 2 weeks
Lesion detection yield
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Background: PubMed 23687601Liao 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.
- Background: PubMed 27211503Liao 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.
- Background: PubMed 30858305Wu 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.
- Background: PubMed 31251929Ding 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhuan Liao study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capsule Endoscopy, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Liao (008621-31161004, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203264, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019; AzTrials last refreshed its copy on 28 Oct 2026.