Capsule Endoscopy Clinical Trial
Official title:
Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.
NCT number | NCT03977935 |
Other study ID # | SG-MCCG-UGT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2019 |
Est. completion date | July 25, 2019 |
Verified date | June 2019 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 25, 2019 |
Est. primary completion date | July 18, 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: - Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy - 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 |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circumferential Visualization of the Z-line | Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire Z line (100%) observed. | Through end of examination, up to 30 minutes | |
Secondary | Detection Rate of Duodenal Papilla | Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained | up to 2 days after the examination | |
Secondary | Gastric Examination Time (GET) | Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus). | Through end of examination, up to 30 minutes | |
Secondary | Manipulation Performance Score of the MCCG | The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best. | up to 10 minutes after the examination | |
Secondary | Image Quality Score (Mainly Focus on Clarity) | Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD). | up to 30 minutes after the examination | |
Secondary | The Number of Images Captured for Esophagus and Z-line | The number of images captured by MCCG for esophagus and Z-line. | up to 30 minutes after the examination | |
Secondary | Number of Participants With Lesions in Upper Gastrointestinal Tract | calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG. | up to 2 days after the examination | |
Secondary | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends. | up to 2 days after the examination | |
Secondary | Cleansing Level Score of Z-line Area | The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area. | Through end of examination, up to 30 minutes | |
Secondary | The Incidence of Adverse Events (The Safety of MCCG) | The presence of adverse events within two weeks aftter swallowing MCCG will be recorded. | up to 2 weeks after the examination | |
Secondary | Transit Time of MCCG in Esophagus | Assess the transit time of MCCG in esophagus from starts take images to ends. | up to 2 days after the examination |
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