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NCT Number: NCT02219529

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

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.

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Key information

Conditions

Gastric Diseases, Chronic Gastritis Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Early Gastric Cancer, Gastric Polyps, Gastric Ulcer, Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasms Neoplasms by Site Peptic Ulcer Polyposis, Gastric Stomach Diseases Stomach Neoplasms Stomach Ulcer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 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

Treatment and study plan

MCE

Device

Other names: magnetic-controlled capsule endoscopy

Standard gastroscopy

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Chinese PLA General Hospital
  • General Hospital of Beijing PLA Military Region
  • Nanfang Hospital, Southern Medical University
  • Peking Union Medical College Hospital
  • RenJi Hospital
  • Shandong Provincial Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial

Acronym: MCE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2014
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.

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