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Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy

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ClinicalTrials.gov Identifier: NCT01903629
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 21, 2015
Sponsor:
Collaborators:
Second Military Medical University
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Condition or disease Intervention/treatment Phase
Gastric Symptoms Indicated for Upper GI Endoscopy Device: MCE Device: Standard gastroscopy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: magnetic-controlled capsule endoscocpy (MCE)
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: MCE
MCE first, followed by standard gastroscopy

Device: Standard gastroscopy



Primary Outcome Measures :
  1. Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Examination times of capsule and standard gastroscopy [ Time Frame: 1 hour ]
  2. Patient acceptance of capsule gastroscopy and standard gastroscopy [ Time Frame: 3 days ]
  3. Adverse events of both procedures [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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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 with gastric symptoms and indicated for Upper GI endoscopy
  • 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): NCT01903629


Locations
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China
Shanghai Changhai Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Second Military Medical University
Wuhan Union Hospital, China