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Magnetic-assisted Capsule Endoscope With 3D Images in EV Detection in Cirrhotic Patient

NCT04588974 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Esophageal Varices in Cirrhosis of the Liver

Interventions

DEVICE

magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images

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.

Sponsors & Collaborators

  • Insight Medical Solution, Inc.

    collaborator UNKNOWN

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588974 on ClinicalTrials.gov