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.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
June 3, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedResults Posted
Study results publicly available
October 27, 2020
CompletedOctober 27, 2020
June 1, 2019
2 months
June 3, 2019
July 27, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Detection Rate of Duodenal Papilla
up to 2 days after the examination
Gastric Examination Time (GET)
Through end of examination, up to 30 minutes
Manipulation Performance Score of the MCCG
up to 10 minutes after the examination
Image Quality Score (Mainly Focus on Clarity)
up to 30 minutes after the examination
The Number of Images Captured for Esophagus and Z-line
up to 30 minutes after the examination
- +5 more secondary outcomes
Study Arms (2)
The first-generation MCCG group
NO INTERVENTIONThe 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.
The second-generation MCCG group
EXPERIMENTALAll process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
Interventions
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, 200433, China
Related Publications (1)
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.
PMID: 31981648DERIVED
Results Point of Contact
- Title
- Investigator of Clinical Trials
- Organization
- Changhai Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 3, 2019
First Posted
June 6, 2019
Study Start
May 10, 2019
Primary Completion
July 18, 2019
Study Completion
July 25, 2019
Last Updated
October 27, 2020
Results First Posted
October 27, 2020
Record last verified: 2019-06