Clinical trial NCT03977935: The Second-Generation MCCG for Upper Gastrointestinal Tract.
Official title: Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsule Endoscopy
Keywords: SG-MCCG
Z-line visualization
Image quality
Gastric examination time
Manipulation performance
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circumferential Visualization of the Z-line
timeFrame: Through end of examination, up to 30 minutes
Secondary outcomes:
measure: Detection Rate of Duodenal Papilla
timeFrame: up to 2 days after the examination
measure: Gastric Examination Time (GET)
timeFrame: Through end of examination, up to 30 minutes
measure: Manipulation Performance Score of the MCCG
timeFrame: up to 10 minutes after the examination
measure: Image Quality Score (Mainly Focus on Clarity)
timeFrame: up to 30 minutes after the examination
measure: The Number of Images Captured for Esophagus and Z-line
timeFrame: up to 30 minutes after the examination
measure: Number of Participants With Lesions in Upper Gastrointestinal Tract
timeFrame: up to 2 days after the examination
measure: Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
timeFrame: up to 2 days after the examination
measure: Cleansing Level Score of Z-line Area
timeFrame: Through end of examination, up to 30 minutes
measure: The Incidence of Adverse Events (The Safety of MCCG)
timeFrame: up to 2 weeks after the examination
measure: Transit Time of MCCG in Esophagus
timeFrame: up to 2 days after the examination
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References:
citation: 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.