The Second-Generation MCCG for Upper Gastrointestinal Tract.

Capsule Endoscopy Clinical Trial

Official title:

Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977935
• Other study ID #: SG-MCCG-UGT
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: July 25, 2019

Study information

• Verified date: June 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Device:
• the second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

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