<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219529</url>
  </required_header>
  <id_info>
    <org_study_id>MCE-1</org_study_id>
    <nct_id>NCT02219529</nct_id>
  </id_info>
  <brief_title>Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases</brief_title>
  <acronym>MCE</acronym>
  <official_title>Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Beijing PLA Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's&#xD;
      approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy&#xD;
      of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging&#xD;
      results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse&#xD;
      and focal diseases in stomach, we performed this single-blinded multi-center prospective&#xD;
      study compared MCE with gastroscopy in patients with gastric symptoms and indication for&#xD;
      upper GI Endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volume of water and drugs used for gastric preparation</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of the cleanliness of stomach after preparation</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examination times of MCE and standard gastroscopy</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptance of MCE and standard gastroscopy</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events of both procedures</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Gastric Diseases,</condition>
  <condition>Gastric Ulcer,</condition>
  <condition>Gastric Polyps,</condition>
  <condition>Early Gastric Cancer,</condition>
  <condition>Chronic Gastritis</condition>
  <arm_group>
    <arm_group_label>MCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients were assigned to swallow MCE first, followed by the gastroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard gastroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients were assigned to swallow MCE first, followed by the gastroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MCE</intervention_name>
    <arm_group_label>MCE</arm_group_label>
    <other_name>magnetic-controlled capsule endoscopy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard gastroscopy</intervention_name>
    <arm_group_label>Standard gastroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presented with gastric symptoms and ready for the first Upper GI endoscopy&#xD;
&#xD;
          -  Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early&#xD;
             gastric cancer, gastric stromal tumors and so on.&#xD;
&#xD;
          -  Age of 18 years to 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with impaired bowel movement from ileus or organic digestive diseases&#xD;
&#xD;
          -  Patients with known large and obstructing tumors of the upper GI tract&#xD;
&#xD;
          -  Patients after upper GI surgery or abdominal surgery altering GI anatomy&#xD;
&#xD;
          -  Patients under full anticoagulation&#xD;
&#xD;
          -  Patient in poor general condition&#xD;
&#xD;
          -  Patients using equipment that may be affected by radio transmission&#xD;
&#xD;
          -  Patients using equipment that may be affected by magnetic field&#xD;
&#xD;
          -  Pregnancy or suspected pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaoshen Li, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.csde.org.cn/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>23687601</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20152309</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>July 19, 2015</last_update_submitted>
  <last_update_submitted_qc>July 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhaoshen Li</investigator_full_name>
    <investigator_title>Director of Gastroenterology Dept.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Stomach Ulcer</mesh_term>
    <mesh_term>Stomach Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219529
org study id: MCE-1
nct id: NCT02219529
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
time frame: 2 days
measure: Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
time frame: 2 days
measure: Volume of water and drugs used for gastric preparation
time frame: 1 hour
measure: Scores of the cleanliness of stomach after preparation
time frame: 1 day
measure: 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
measure: Examination times of MCE and standard gastroscopy
time frame: 1 day
measure: Patient acceptance of MCE and standard gastroscopy
time frame: 3 days
measure: Adverse events of both procedures
time frame: 2 weeks
arm group label: MCE
arm group type: Experimental
description: patients were assigned to swallow MCE first, followed by the gastroscopy
arm group label: Standard gastroscopy
arm group type: Active Comparator
description: patients were assigned to swallow MCE first, followed by the gastroscopy
intervention type: Device
intervention name: MCE
arm group label: MCE
other name: magnetic-controlled capsule endoscopy
intervention type: Device
intervention name: Standard gastroscopy
arm group label: Standard gastroscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhaoshen Li, Prof.
role: Principal Investigator
affiliation: Changhai Hospital
facility: 
country: China
url: http://www.csde.org.cn/
description: Related Info
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.
PMID: 23687601
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.
PMID: 20152309
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhaoshen Li
investigator title: Director of Gastroenterology Dept.
mesh term: Gastritis
mesh term: Stomach Ulcer
mesh term: Stomach Diseases