Capsule Endoscopy Clinical Trial
Official title:
Feasibility of Using Magnetically-controlled Capsule Endoscopy for Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
Verified date | April 2020 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 14, 2020 |
Est. primary completion date | October 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Suspected or known gastrointestinal stenosis - Obstruction or other known risk factors for capsule retention - Pregnancy or suspected pregnancy - Pacemakers or electromedical devices implanted - Any other contraindications determined by endoscopists |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sucralfate gel adhesion behavior in the fasted gastric cavity | The adhesion time was recorded from the sucralfate gel entered the stomach to all sucralfate adhered to the gastric wall. | 180 minutes | |
Primary | Sucralfate gel distribution behavior in the fasted gastric cavity | The distribution area of sucralfate gel was measured by selecting images of six primary anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus) at different times, the images were imported into MATLAB software to calculate the area of sucrafate gel. The dynamic changes of distribution area of sucralfate gel over the time were analyzed and performed with GraphPad Prism. | 0, 30, 60, 90, 150, 180 min after dyed sucralfate gel enter the stomach | |
Primary | Sucralfate gel dissipation behavior in the fasted gastric cavity | The dissipation time was evaluated by calculating the times between sucralfate gel entered the stomach and adhered sucralfate disappeared completely. | 180 minutes | |
Secondary | Number of Participants with complications of MCE | Any complications associated with MCE. | 2 weeks | |
Secondary | Discomfort scores of participants during the procedure | The discomfort associated with the procedure included swallow difficulty, nausea caused by string, pulling capsule up and down, abdominal distension or pain caused by ingesting aerogenic powder, discomfort during MCE examination, and pulling the string out. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 = mild/minimal; 2 = moderate; 3 = sever/very difficult). | during the procedure |
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