The Second-Generation MCCG for Upper Gastrointestinal Tract.
NCT ID: NCT03977935
Last Updated: 2020-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-05-10
2019-07-25
Brief Summary
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Detailed Description
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Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.
This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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The first-generation MCCG group
The patients swallowed the first-generation MCCG 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. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
No interventions assigned to this group
The second-generation MCCG group
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Interventions
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the second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo a capsule endoscopy for both stomach and small bowel
* Signed the informed consents before joining this study
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhuan Liao
Clinical Professor
Locations
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Changhai Hospital
Shanghai, , China
Countries
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References
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Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SG-MCCG-UGT
Identifier Type: -
Identifier Source: org_study_id