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/NCT06027060</url>
    </required_header>
    <id_info>
      <org_study_id>Renjixh202301</org_study_id>
      <nct_id>NCT06027060</nct_id>
    </id_info>
    <brief_title>Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy</brief_title>
    <official_title>Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Jiao Tong University School of Medicine</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>
        The objective of this study is to observe gastric mucosal injuries in NSAID and non-NSAID&#xD;
        users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on&#xD;
        gastric mucosal damage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A&#xD;
        major limitation to their use is the adverse effects they cause on the gastrointestinal&#xD;
        tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage&#xD;
        to the healing of gastric ulcers. The purpose of this prospective, single-center study was to&#xD;
        monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron&#xD;
        capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.&#xD;
  &#xD;
        For people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and&#xD;
        timely intervention treatment is required if relevant lesions are found, and the medication&#xD;
        plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no&#xD;
        anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is&#xD;
        a beneficial supplement to traditional gastroscopy, so that some people with absolute or&#xD;
        relative contraindications of traditional gastroscopy can get timely endoscopy, and can be&#xD;
        diagnosed and treated early.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Gastric diseases detected</measure>
      <time_frame>1 day</time_frame>
      <description>Gastric diseases detected</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gastric mucosal injury by Lanza score</measure>
      <time_frame>1 day</time_frame>
      <description>Gastric mucosal injury by Lanza score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric transit time</measure>
      <time_frame>1 day</time_frame>
      <description>Gastric transit time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric cleanliness</measure>
      <time_frame>1 day</time_frame>
      <description>Gastric cleanliness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effects of NSAID duration on gastric injury</measure>
      <time_frame>1 day</time_frame>
      <description>Effects of NSAID duration on gastric injury</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effects of NSAID dosage on gastric injury</measure>
      <time_frame>1 day</time_frame>
      <description>Effects of NSAID dosage on gastric injury</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">180</enrollment>
    <condition>NSAID-Associated Gastropathy</condition>
    <arm_group>
      <arm_group_label>NSAIDs users</arm_group_label>
      <description>90 patients taking NSAIDs for over 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-NSAIDs users</arm_group_label>
      <description>90 non-NSAIDs users undergoing physical examination</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Ninety patients receiving NSAIDS (more than 3 months) and undergoing magnetron capsule&#xD;
          gastroscopy at Renji Hospital were included, and 90 patients not taking NSAIDS and&#xD;
          undergoing magnetron capsule gastroscopy at the same time were included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Planned magnetically-controlled capsule gastroscopy&#xD;
  &#xD;
            -  NSAID use &gt;3 months or no NSAID use&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it&#xD;
               cannot be removed surgically);&#xD;
  &#xD;
            -  Cardiac pacemakers (except MRI-compatible ones);&#xD;
  &#xD;
            -  Electronic implants or metal foreign bodies;&#xD;
  &#xD;
            -  Pregnant women;&#xD;
  &#xD;
            -  Known or suspected GI obstruction, stenosis, fistula;&#xD;
  &#xD;
            -  Dysphagia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hui-Min H Chen, MD</last_name>
      <phone>021-68383015</phone>
      <email>chenhuimin@renji.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <zip>200001</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
      <investigator_full_name>Xiaobo Li</investigator_full_name>
      <investigator_title>Chief physician</investigator_title>
    </responsible_party>
    <keyword>Magnetically-controlled Capsule Endoscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06027060
  org study id: Renjixh202301
  nct id: NCT06027060
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to observe gastric mucosal injuries in NSAID and non-NSAID
        users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on
        gastric mucosal damage.
  Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A
        major limitation to their use is the adverse effects they cause on the gastrointestinal
        tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage
        to the healing of gastric ulcers. The purpose of this prospective, single-center study was to
        monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron
        capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.
  
        For people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and
        timely intervention treatment is required if relevant lesions are found, and the medication
        plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no
        anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is
        a beneficial supplement to traditional gastroscopy, so that some people with absolute or
        relative contraindications of traditional gastroscopy can get timely endoscopy, and can be
        diagnosed and treated early.
  observational model: Case-Control
  time perspective: Prospective
  measure: Gastric diseases detected
  time frame: 1 day
  description: Gastric diseases detected
  measure: Gastric mucosal injury by Lanza score
  time frame: 1 day
  description: Gastric mucosal injury by Lanza score
  measure: Gastric transit time
  time frame: 1 day
  description: Gastric transit time
  measure: Gastric cleanliness
  time frame: 1 day
  description: Gastric cleanliness
  measure: Effects of NSAID duration on gastric injury
  time frame: 1 day
  description: Effects of NSAID duration on gastric injury
  measure: Effects of NSAID dosage on gastric injury
  time frame: 1 day
  description: Effects of NSAID dosage on gastric injury
  arm group label: NSAIDs users
  description: 90 patients taking NSAIDs for over 3 months
  arm group label: non-NSAIDs users
  description: 90 non-NSAIDs users undergoing physical examination
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hui-Min H Chen, MD
  phone: 021-68383015
  email: chenhuimin@renji.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Jiao Tong University School of Medicine
  investigator full name: Xiaobo Li
  investigator title: Chief physician
  mesh term: Stomach Diseases
  sharing ipd: No