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OpenTrials
Completed

NCT Number: NCT01903629

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

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.

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Key information

Conditions

Gastric Symptoms Indicated for Upper GI Endoscopy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Changhai Hospital

Shanghai, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCE

Device

MCE first, followed by standard gastroscopy

Standard gastroscopy

Device

Primary outcomes

  1. Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions

    Time frame: 2 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Second Military Medical University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 19, 2013
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.