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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219529
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : July 21, 2015
Sponsor:
Collaborators:
RenJi Hospital
Nanfang Hospital of 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
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Diseases, Gastric Ulcer, Gastric Polyps, Early Gastric Cancer, Chronic Gastritis Device: MCE Device: Standard gastroscopy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
Study Start Date : August 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MCE
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: MCE
Other Name: magnetic-controlled capsule endoscopy

Active Comparator: Standard gastroscopy
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: Standard gastroscopy



Primary Outcome Measures :
  1. Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy [ Time Frame: 2 days ]
  2. Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Volume of water and drugs used for gastric preparation [ Time Frame: 1 hour ]
  2. Scores of the cleanliness of stomach after preparation [ Time Frame: 1 day ]
  3. 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 ]
  4. Examination times of MCE and standard gastroscopy [ Time Frame: 1 day ]
  5. Patient acceptance of MCE and standard gastroscopy [ Time Frame: 3 days ]
  6. Adverse events of both procedures [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219529


Locations
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China
Shanghai Changhai Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
RenJi Hospital
Nanfang Hospital of 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
Investigators
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Principal Investigator: Zhaoshen Li, Prof. Changhai Hospital
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
ClinicalTrials.gov Identifier: NCT02219529    
Other Study ID Numbers: MCE-1
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Gastritis
Stomach Ulcer
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases