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/NCT06029608</url>
    </required_header>
    <id_info>
      <org_study_id>Renji202302</org_study_id>
      <nct_id>NCT06029608</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases</brief_title>
    <official_title>Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases</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 prospective, observational, controlled clinical study is to use&#xD;
        magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients&#xD;
        and patients with underlying diseases, to evaluate its clinical efficacy and safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gastric cancer is the most common digestive tract malignancy in China, which severely impacts&#xD;
        human health and quality of life. Currently, surgery is the main treatment for gastric&#xD;
        cancer. Since the surgery removes part or all of the stomach for malignant tumor, various&#xD;
        postoperative complications inevitably occur. The occurrence of postoperative complications&#xD;
        is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is&#xD;
        necessary to closely monitor for upper gastrointestinal symptoms and periodically examine&#xD;
        intragastric lesions in order to make timely diagnosis and treatment, and improve quality of&#xD;
        life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly&#xD;
        patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular&#xD;
        diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy&#xD;
        has the advantages of being completely painless, convenient, highly accurate in diagnosis,&#xD;
        and well-accepted by patients. It is more suitable for postoperative assessment in elderly&#xD;
        patients and patients with underlying diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">October 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>Detection of gastric lesions (or postoperative complications)</measure>
      <time_frame>1 day</time_frame>
      <description>Detection of gastric lesions (or postoperative complications)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Upper gastrointestinal discomfort symptoms or not</measure>
      <time_frame>1 day</time_frame>
      <description>Patients have or no upper gastrointestinal discomfort symptoms after surgery (such as nausea, vomiting, acid reflux, belching, bloating, postprandial fullness, and early satiety), judging by the patient's chief complaint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' comfort during the procedure</measure>
      <time_frame>1 day</time_frame>
      <description>Use BCS to evaluate patients' comfort during the procedure (BCS is Bruggrmann comfort scale, a 5-point scale of 0 to 4, with a higher score indicating higher comfort.)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric clarity and visibility</measure>
      <time_frame>1 day</time_frame>
      <description>Assess the clarity and visibility of the stomach. The clarity and visibility of the field of vision is divided into three categories, that is, class I: the field of vision is clear, and the part and mucosa can be accurately observed; Class II: Vision is not clear, but can still distinguish the part; Class III: Cloudy vision, unable to distinguish the area.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group</measure>
      <time_frame>1 day</time_frame>
      <description>Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Evaluation,Efficacy,Safety</condition>
    <arm_group>
      <arm_group_label>Magnetically-controlled Capsule endoscopy group</arm_group_label>
      <description>Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional endoscopy group</arm_group_label>
      <description>Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Elderly patients (older than 65 years) and patients with underlying diseases&#xD;
          (cardiovascular, respiratory, hemorrhagic diseases, etc.) who underwent surgery for gastric&#xD;
          malignant tumors (including surgical resection and ESD).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Planned to undergo magnetic-controlled capsule gastroscopy or conventional endoscopy,&#xD;
               and have undergone surgery for gastric malignant tumors (including surgical resection&#xD;
               and ESD), elderly patients (older than 65 years) or patients with underlying diseases&#xD;
               (cardiovascular, respiratory, hemorrhagic diseases, etc.);&#xD;
  &#xD;
            -  Agree to participate in this clinical trial and sign the informed consent form.&#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>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hui-Min H Chen, MD</last_name>
      <phone>02168383015</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>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>
    <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/NCT06029608
  org study id: Renji202302
  nct id: NCT06029608
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this prospective, observational, controlled clinical study is to use
        magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients
        and patients with underlying diseases, to evaluate its clinical efficacy and safety.
  Gastric cancer is the most common digestive tract malignancy in China, which severely impacts
        human health and quality of life. Currently, surgery is the main treatment for gastric
        cancer. Since the surgery removes part or all of the stomach for malignant tumor, various
        postoperative complications inevitably occur. The occurrence of postoperative complications
        is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is
        necessary to closely monitor for upper gastrointestinal symptoms and periodically examine
        intragastric lesions in order to make timely diagnosis and treatment, and improve quality of
        life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly
        patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular
        diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy
        has the advantages of being completely painless, convenient, highly accurate in diagnosis,
        and well-accepted by patients. It is more suitable for postoperative assessment in elderly
        patients and patients with underlying diseases.
  observational model: Case-Control
  time perspective: Prospective
  measure: Detection of gastric lesions (or postoperative complications)
  time frame: 1 day
  description: Detection of gastric lesions (or postoperative complications)
  measure: Upper gastrointestinal discomfort symptoms or not
  time frame: 1 day
  description: Patients have or no upper gastrointestinal discomfort symptoms after surgery (such as nausea, vomiting, acid reflux, belching, bloating, postprandial fullness, and early satiety), judging by the patient's chief complaint.
  measure: Patients' comfort during the procedure
  time frame: 1 day
  description: Use BCS to evaluate patients' comfort during the procedure (BCS is Bruggrmann comfort scale, a 5-point scale of 0 to 4, with a higher score indicating higher comfort.)
  measure: Gastric clarity and visibility
  time frame: 1 day
  description: Assess the clarity and visibility of the stomach. The clarity and visibility of the field of vision is divided into three categories, that is, class I: the field of vision is clear, and the part and mucosa can be accurately observed; Class II: Vision is not clear, but can still distinguish the part; Class III: Cloudy vision, unable to distinguish the area.
  measure: Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
  time frame: 1 day
  description: Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
  arm group label: Magnetically-controlled Capsule endoscopy group
  description: Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases
  arm group label: Conventional endoscopy group
  description: Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hui-Min H Chen, MD
  phone: 02168383015
  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
  sharing ipd: No