Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
MCE
1 other identifier
interventional
350
1 country
1
Brief Summary
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2014
Shorter than P25 for phase_3
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
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 21, 2015
July 1, 2015
5 months
August 12, 2014
July 19, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
2 days
Secondary Outcomes (6)
Volume of water and drugs used for gastric preparation
1 hour
Scores of the cleanliness of stomach after preparation
1 day
Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
1 day
Examination times of MCE and standard gastroscopy
1 day
Patient acceptance of MCE and standard gastroscopy
3 days
- +1 more secondary outcomes
Study Arms (2)
MCE
EXPERIMENTALpatients were assigned to swallow MCE first, followed by the gastroscopy
Standard gastroscopy
ACTIVE COMPARATORpatients were assigned to swallow MCE first, followed by the gastroscopy
Interventions
Eligibility Criteria
You may qualify if:
- Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
- Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
- Age of 18 years to 70 years
You may not qualify if:
- Patients with impaired bowel movement from ileus or organic digestive diseases
- Patients with known large and obstructing tumors of the upper GI tract
- Patients after upper GI surgery or abdominal surgery altering GI anatomy
- Patients under full anticoagulation
- Patient in poor general condition
- Patients using equipment that may be affected by radio transmission
- Patients using equipment that may be affected by magnetic field
- Pregnancy or suspected pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- RenJi Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Chinese PLA General Hospitalcollaborator
- General Hospital of Beijing PLA Military Regioncollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Shandong Provincial Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
Study Sites (1)
Shanghai Changhai Hospital
Shanghai, 200433, China
Related Publications (3)
Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
PMID: 23687601BACKGROUNDLiao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
PMID: 20152309BACKGROUNDLiao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
PMID: 27211503DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, Prof.
Changhai Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology Dept.
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 19, 2014
Study Start
August 1, 2014
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
July 21, 2015
Record last verified: 2015-07