The Second-Generation MCCG for Upper Gastrointestinal Tract.

Not Applicable

Completed

Conditions: Capsule Endoscopy

Registration Number: NCT03977935

Lead Sponsor: Changhai Hospital

Brief Summary: 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.

Detailed Description: Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Circumferential Visualization of the Z-line	Through end of examination, up to 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Detection Rate of Duodenal Papilla	up to 2 days after the examination	Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained
Image Quality Score (Mainly Focus on Clarity)	up to 30 minutes after the examination	Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
The Incidence of Adverse Events (The Safety of MCCG)	up to 2 weeks after the examination	The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.
Gastric Examination Time (GET)	Through end of examination, up to 30 minutes	Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time	up to 2 days after the examination	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.
Cleansing Level Score of Z-line Area	Through end of examination, up to 30 minutes	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.
Manipulation Performance Score of the MCCG	up to 10 minutes after the examination	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.
The Number of Images Captured for Esophagus and Z-line	up to 30 minutes after the examination	The number of images captured by MCCG for esophagus and Z-line.
Number of Participants With Lesions in Upper Gastrointestinal Tract	up to 2 days after the examination	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.
Transit Time of MCCG in Esophagus	up to 2 days after the examination	Assess the transit time of MCCG in esophagus from starts take images to ends.