Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient
1 other identifier
observational
140
1 country
1
Brief Summary
Newly development of capsule endoscopy provides a comfortable and minimal invasive modality which is an alternative to conventional esophagogastroduodenoscopy(EGD). The use of capsule endoscopy beyond the small bowel is increasing and several capsule endoscopy systems have been introduced for the examination of the esophagus and colon. The current capsule endoscopy systems are less effective for the upper gastrointestinal tract examination. Short transit time in the esophagus and the passive movement of the capsule makes it more difficult to identify or visualize the lesion comparing with traditional EGD. The sensitivity rate of esophageal varices detection from capsule endoscopy was ranging from 65% to 80%. In order to control the capsule in the gastrointestinal tract for better visualization, many methods are invented. Magnetically assisted capsule endoscopy systems and string-mounted capsule endoscopy are applied in many studies. Magnetically assisted capsule endoscopy system and string-mounted capsule endoscopy are used to control the capsule endoscopy for elongating esophagus transit time to have a better visualization of the esophagus. The InsightEyes EGD System combines the string and magnetic assisted capsule endoscopy system to provide a real-time high-quality image during the examination. On the other hand, 3D image processing can be used for distinguishing the esophageal varices and normal folds well, theoretically. Thus, in this study, the investigators combine string, magnetically assisted capsule endoscopy systems, and 3D image processing together to form a new system for improving the detection of esophageal varices and other gastric lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedOctober 19, 2020
October 1, 2020
1.8 years
October 4, 2020
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
esophageal detection rate
The investigators compare the detection rate of esophageal varices in the cirrhotic patients in the MACE system and 3D image processing with conventional EGD.
upto 1 week after MACE and EGD
esophageal grading
The investigators compare the grading consistency in the patients who have the esophageal varices between the two modalities, using the conventional EGD as gold standard.
upto 1 week after MACE and EGD
Secondary Outcomes (3)
image quality
upto 1 week after MACE and EGD
gastric lesion comparison
upto 1 week after MACE and EGD
preference in MACE or EGD
upto 1 week after MACE and EGD
Study Arms (3)
Screening
Sixty-five cirrhotic patients with portal hypertensive symptoms (such as platelets count less than 100,000) will be enrolled to evaluate for the presence and stage of esophageal varices by using a magnetic-assisted capsule endoscope system with or without 3D image processing.
Follow-up
Thirty-five cirrhotic patients with a history of endoscopy-confirmed esophageal varices will be included for the follow-up examination by using the magnetic-assisted capsule endoscope system with or without 3D images.
Control
Another 40 volunteers with GI symptoms but no known gastrointestinal disease will be enrolled as the control group.
Interventions
The patient will undergo both diagnostic tests within two days, a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
Eligibility Criteria
The investigators plan to include a total of 140 participants in this study. Sixty-five cirrhotic patients with portal hypertensive symptoms (such as platelets count less than 100,000) will be enrolled to evaluate for the presence and stage of esophageal varices by using a magnetic-assisted capsule endoscope system with or without 3D image processing. Thirty-five cirrhotic patients with a history of endoscopy-confirmed esophageal varices will be included for the follow-up examination by using the magnetic-assisted capsule endoscope system with or without 3D images. Another 40 healthy volunteers without known gastrointestinal disease will be enrolled as the control group.
You may qualify if:
- The investigators plan to include a total of 140 participants in this study, aged from 20 to 75-year-old.
You may not qualify if:
- Those participants with less than 20-year-old, having implanted electronic or magnetic devices, pregnant, or unable to swallow the capsule, will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endoscopy Center for Diagnosis and Treatment, Department of Medicine, Taipei Veterans General Hospital
Taipei, 112, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2020
First Posted
October 19, 2020
Study Start
October 15, 2020
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
October 19, 2020
Record last verified: 2020-10