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Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases (MCE)

Primary Purpose

Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MCE
Standard gastroscopy
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Diseases,

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCE

Standard gastroscopy

Arm Description

patients were assigned to swallow MCE first, followed by the gastroscopy

patients were assigned to swallow MCE first, followed by the gastroscopy

Outcomes

Primary Outcome Measures

Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy

Secondary Outcome Measures

Volume of water and drugs used for gastric preparation
Scores of the cleanliness of stomach after preparation
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
Examination times of MCE and standard gastroscopy
Patient acceptance of MCE and standard gastroscopy
Adverse events of both procedures

Full Information

First Posted
August 12, 2014
Last Updated
July 19, 2015
Sponsor
Changhai Hospital
Collaborators
RenJi Hospital, Nanfang Hospital, Southern Medical University, Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Wuhan Union Hospital, China, Shandong Provincial Hospital, Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02219529
Brief Title
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
Acronym
MCE
Official Title
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
RenJi Hospital, Nanfang Hospital, Southern Medical University, Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Wuhan Union Hospital, China, Shandong Provincial Hospital, Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,, Early Gastric Cancer,, Chronic Gastritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCE
Arm Type
Experimental
Arm Description
patients were assigned to swallow MCE first, followed by the gastroscopy
Arm Title
Standard gastroscopy
Arm Type
Active Comparator
Arm Description
patients were assigned to swallow MCE first, followed by the gastroscopy
Intervention Type
Device
Intervention Name(s)
MCE
Other Intervention Name(s)
magnetic-controlled capsule endoscopy
Intervention Type
Device
Intervention Name(s)
Standard gastroscopy
Primary Outcome Measure Information:
Title
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Time Frame
2 days
Title
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Volume of water and drugs used for gastric preparation
Time Frame
1 hour
Title
Scores of the cleanliness of stomach after preparation
Time Frame
1 day
Title
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
Time Frame
1 day
Title
Examination times of MCE and standard gastroscopy
Time Frame
1 day
Title
Patient acceptance of MCE and standard gastroscopy
Time Frame
3 days
Title
Adverse events of both procedures
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, Prof.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23687601
Citation
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.
Results Reference
background
PubMed Identifier
20152309
Citation
Liao 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.
Results Reference
background
PubMed Identifier
27211503
Citation
Liao 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.
Results Reference
derived
Links:
URL
http://www.csde.org.cn/
Description
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Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases

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