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/NCT06002737</url>
    </required_header>
    <id_info>
      <org_study_id>RTS-018</org_study_id>
      <nct_id>NCT06002737</nct_id>
    </id_info>
    <brief_title>The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial</brief_title>
    <official_title>The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hecheng Li M.D., Ph.D</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ruijin Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluation of the safety and effectiveness of disposable ultrasound soft tissue cutting and&#xD;
        hemostasis equipment for coagulating 5-7mm blood vessels with ultrasound scalpel tips&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Screening lung and esophageal surgery patients who must meet the inclusion/exclusion&#xD;
        criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of&#xD;
        5-7mm blood vessel disconnection and occlusion&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife</measure>
      <time_frame>From the target Vascular detachment to finish of the surgery</time_frame>
      <description>The success rate is defined as the number of subjects who successfully occluded and severed blood vessels divided by the number of subjects in the analysis dataset. Each subject should use an ultrasound knife to occlude and sever at least one target vessel</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Using Experimental harmonic scalpel to dissect the vessel</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel</intervention_name>
      <description>Screening of lung or esophageal surgery patients who meet the inclusion criteria but do not meet the exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of coagulation of blood vessels with a diameter greater than 5mm but not equal to 7mm.</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) 18 years old ≤ age ≤ 75 years old, regardless of gender;&#xD;
  &#xD;
               2) Based on the preoperative CT examination results, it is determined that the patient&#xD;
               has at least one blood vessel that needs to be coagulated during the surgery, with a&#xD;
               diameter greater than 5mm but less than or equal to 7mm;&#xD;
  &#xD;
               3) Before the start of the study, the patient is willing and able to sign an informed&#xD;
               consent form approved by the ethics committee;&#xD;
  &#xD;
               4) The patient understands the clinical study, cooperates with the research procedure,&#xD;
               and is willing to conduct postoperative follow-up according to the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) Patient body mass index (BMI) ≥ 35.0 kg/m2;&#xD;
  &#xD;
               2) Prothrombin time greater than 5 seconds;&#xD;
  &#xD;
               3) Researchers have determined that the tumor may invade the target blood vessel,&#xD;
               which may affect the operation or effectiveness of vascular occlusion and&#xD;
               disconnection;&#xD;
  &#xD;
               4) Researchers have determined that there may be variations, deformities, or&#xD;
               calcifications in the target vessel that may affect the evaluation of the primary&#xD;
               endpoint, which may affect the operation or effectiveness of vascular occlusion and&#xD;
               disconnection;&#xD;
  &#xD;
               5) Patients receive preoperative chemotherapy and radiation therapy;&#xD;
  &#xD;
               6) Patient's fasting blood glucose ≥ 11.1mmol/l;&#xD;
  &#xD;
               7) Hypertensive patients' blood pressure has not been effectively controlled, and&#xD;
               their blood pressure is ≥ 140/90 millimeter of mercury （mmHg） in a stable state after&#xD;
               medication;&#xD;
  &#xD;
               8) Pregnant or lactating women, or women with pregnancy plans during the trial period;&#xD;
  &#xD;
               9) Participated in other clinical studies within 3 months;&#xD;
  &#xD;
               10) Individuals with mental disorders and lack of autonomous behavioral ability;&#xD;
  &#xD;
               11) Other researchers believe that it is not suitable to participate in the&#xD;
               experiment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Shanghai Jiao Tong University School of Medicine Ruijin Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hecheng Li, MD/PHD</last_name>
        <phone>021-64370045</phone>
        <email>lhc11863@rjh.com.cn</email>
      </contact>
      <contact_backup>
        <last_name>Chengqiang Li, MD/PHD</last_name>
        <phone>13524282905</phone>
        <email>lcq12305@rjh.com.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
      <investigator_full_name>Hecheng Li M.D., Ph.D</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06002737
  org study id: RTS-018
  nct id: NCT06002737
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Evaluation of the safety and effectiveness of disposable ultrasound soft tissue cutting and
        hemostasis equipment for coagulating 5-7mm blood vessels with ultrasound scalpel tips
  Screening lung and esophageal surgery patients who must meet the inclusion/exclusion
        criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of
        5-7mm blood vessel disconnection and occlusion
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife
  time frame: From the target Vascular detachment to finish of the surgery
  description: The success rate is defined as the number of subjects who successfully occluded and severed blood vessels divided by the number of subjects in the analysis dataset. Each subject should use an ultrasound knife to occlude and sever at least one target vessel
  arm group label: Arm 1
  arm group type: Experimental
  description: Using Experimental harmonic scalpel to dissect the vessel
  arm group label: Arm 2
  arm group type: Active Comparator
  description: Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel
  intervention type: Device
  intervention name: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel
  description: Screening of lung or esophageal surgery patients who meet the inclusion criteria but do not meet the exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of coagulation of blood vessels with a diameter greater than 5mm but not equal to 7mm.
  arm group label: Arm 1
  arm group label: Arm 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ruijin Hospital
  investigator full name: Hecheng Li M.D., Ph.D
  investigator title: Prof
  sharing ipd: Undecided