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Feasibility of Using Magnetically-controlled Capsule Endoscopy for Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
The investigators aim to explore the feasibility of MCE in direct, real-time visualization of drug behavior in upper-gastrointestinal tract, which presented by the adhesion, distribution, and dissipation characteristics of dyed sucralfate gel.
This pilot study was a prospective, single-centered, nonrandomized study. The investigators selected 10 subjects from patients with a recent history of upper-gastrointestinal symptoms who met the indication of taking sucralfate suspension gel, and another 10 subjects from healthy volunteers. Procedures were performed by the NaviCam magnetic capsule guidance system. To enhance discrimination, the sucralfate gel dyed with 0.3 ml methylene blue. The subjects swallowed the capsule with water in the left lateral position. When capsule enter stomach cavity, subject was asked to sit up and ingested 4 g aerogenic powder with 5 ml water to distend the stomach, and performed gastric baseline examinations to identify the lesions. After baseline examination, subjects ingested dyed sucralfate gel and performed the first-time examination. The examination was repeated at 30 min intervals, until dyed sucralfate gel disappeared completely. When study completed, the capsule was detached from string and continued into the small bowel for further examination. The endoscopists recorded the adhesion and dissipation times of dyed sucralfate gel, calculated the efficient time, and selected the images of six primary anatomic landmarks from each examination to measure the distribution area (%) . Any complication or discomfort during the procedure was evaluated. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 = mild/minimal; 2 = moderate; 3 = sever/very difficult).
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Changhai Hospital
Shanghai, China
Start Date
November 3, 2018
Primary Completion Date
October 22, 2019
Completion Date
February 14, 2020
Last Updated
April 28, 2020
20
ACTUAL participants
Magnetically controlled capsule endoscopy
DEVICE
Lead Sponsor
Changhai Hospital
NCT04479423
NCT05073536
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View ClinicalTrials.gov Terms and ConditionsNCT05228379