The Second-Generation MCCG for Upper Gastrointestinal Tract.

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

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.

Study Overview

• Status: Completed
• Conditions: Capsule Endoscopy
• Intervention / Treatment: Device: the second-generation MCCG

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The first-generation MCCG group; The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
Experimental: The second-generation MCCG group; All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.	Device: the second-generation MCCG; Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): July 25, 2019

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Image quality; SG-MCCG; Z-line visualization; Gastric examination time; Manipulation performance
• Other Study ID Numbers: SG-MCCG-UGT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No