xml: <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/NCT06020859</url>
    </required_header>
    <id_info>
      <org_study_id>MCE-new</org_study_id>
      <nct_id>NCT06020859</nct_id>
    </id_info>
    <brief_title>MCE-new for Detection of Gastric Lesions</brief_title>
    <official_title>New MCE System for Detection of Gastric Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Clinical application of magnetically controlled capsule endoscopy : a prospective&#xD;
        self-controlled trial&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to investigate the effectiveness and safety of using a new MCE&#xD;
        system for routine gastric examination and automatic scanning. This study is a prospective,&#xD;
        self controlled clinical trail, which includes adult patients who plan to undergo MCE&#xD;
        examination. Patients will undergo three different tests during the experiment:&#xD;
        NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine&#xD;
        gastric examination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the degree of gastric mucosal visualization</measure>
      <time_frame>2 weeks</time_frame>
      <description>The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, &lt;70% of the gastric mucosa can be observed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The time of gastric examination</measure>
      <time_frame>2 weeks</time_frame>
      <description>The total time MCE required to complete the stomach examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>detection of lesions</measure>
      <time_frame>2 weeks</time_frame>
      <description>The detection of gastric lesions by MCE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Equipment operation evaluation</measure>
      <time_frame>2 weeks</time_frame>
      <description>Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Assessment</measure>
      <time_frame>2 weeks</time_frame>
      <description>Number and incidence of device-related adverse events and serious adverse events</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Capsule Endoscopy</condition>
    <arm_group>
      <arm_group_label>NaviEC-2000Pro Gastro Scan</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NaviEC-2000Pro Routine gastric examination</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NaviEC-1000 Routine gastric examination</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>undergo NaviEC-2000Pro Gastro Scan mode</intervention_name>
      <description>Patients undergo NaviEC-2000Pro Gastro Scan mode.</description>
      <arm_group_label>NaviEC-2000Pro Gastro Scan</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NaviEC-2000Pro Routine gastric examination</intervention_name>
      <description>Patients undergo NaviEC-2000Pro Routine gastric examination mode.</description>
      <arm_group_label>NaviEC-2000Pro Routine gastric examination</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NaviEC-1000 Routine gastric examination</intervention_name>
      <description>Patients undergo NaviEC-1000 Routine gastric examination mode.</description>
      <arm_group_label>NaviEC-1000 Routine gastric examination</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  underwent gastric examination;&#xD;
  &#xD;
            -  At least 18 years old；&#xD;
  &#xD;
            -  Be able to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  With swallowing obstruction or disorders;&#xD;
  &#xD;
            -  With known or suspected gastrointestinal obstruction, stenosis and fistula;&#xD;
  &#xD;
            -  Have no conditions for surgery or refuse to undergo any abdominal surgery;&#xD;
  &#xD;
            -  Be allergic to or have other known contraindication or intolerance to the drug used in&#xD;
               the study;&#xD;
  &#xD;
            -  With pacemakers or other electronic devices such as electronic cochlear implants,&#xD;
               implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal&#xD;
               foreign bodies;&#xD;
  &#xD;
            -  Women during pregnancy;&#xD;
  &#xD;
            -  Currently enrolled in another clinical trial of a drug or device;&#xD;
  &#xD;
            -  Other conditions determined by the investigator to be inappropriate for enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhuan Liao</last_name>
      <phone>86-21-31161004</phone>
      <email>liaozhuan@smmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yangyang Qian</last_name>
    </overall_contact_backup>
    <reference>
      <citation>Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.</citation>
      <PMID>30005825</PMID>
    </reference>
    <reference>
      <citation>Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.</citation>
      <PMID>27211503</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhai Hospital</investigator_affiliation>
      <investigator_full_name>Zhuan Liao</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020859
  org study id: MCE-new
  nct id: NCT06020859
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Clinical application of magnetically controlled capsule endoscopy : a prospective
        self-controlled trial
  The aim of this study is to investigate the effectiveness and safety of using a new MCE
        system for routine gastric examination and automatic scanning. This study is a prospective,
        self controlled clinical trail, which includes adult patients who plan to undergo MCE
        examination. Patients will undergo three different tests during the experiment:
        NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine
        gastric examination.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: the degree of gastric mucosal visualization
  time frame: 2 weeks
  description: The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.
  measure: The time of gastric examination
  time frame: 2 weeks
  description: The total time MCE required to complete the stomach examination
  measure: detection of lesions
  time frame: 2 weeks
  description: The detection of gastric lesions by MCE
  measure: Equipment operation evaluation
  time frame: 2 weeks
  description: Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best
  measure: Safety Assessment
  time frame: 2 weeks
  description: Number and incidence of device-related adverse events and serious adverse events
  arm group label: NaviEC-2000Pro Gastro Scan
  arm group type: Experimental
  description: NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro
  arm group label: NaviEC-2000Pro Routine gastric examination
  arm group type: Experimental
  description: NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro
  arm group label: NaviEC-1000 Routine gastric examination
  arm group type: Active Comparator
  description: NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000
  intervention type: Device
  intervention name: undergo NaviEC-2000Pro Gastro Scan mode
  description: Patients undergo NaviEC-2000Pro Gastro Scan mode.
  arm group label: NaviEC-2000Pro Gastro Scan
  intervention type: Device
  intervention name: NaviEC-2000Pro Routine gastric examination
  description: Patients undergo NaviEC-2000Pro Routine gastric examination mode.
  arm group label: NaviEC-2000Pro Routine gastric examination
  intervention type: Device
  intervention name: NaviEC-1000 Routine gastric examination
  description: Patients undergo NaviEC-1000 Routine gastric examination mode.
  arm group label: NaviEC-1000 Routine gastric examination
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zhuan Liao
  phone: 86-21-31161004
  email: liaozhuan@smmu.edu.cn
  last name: Yangyang Qian
  citation: Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
  PMID: 30005825
  citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
  PMID: 27211503
  responsible party type: Principal Investigator
  investigator affiliation: Changhai Hospital
  investigator full name: Zhuan Liao
  investigator title: Professor