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/NCT06017648</url>
    </required_header>
    <id_info>
      <org_study_id>HJ002-07-001</org_study_id>
      <nct_id>NCT06017648</nct_id>
    </id_info>
    <brief_title>A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction</brief_title>
    <official_title>Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled Trial on the Efficacy and Safety of the Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Carnation Medical Technology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Carnation Medical Technology Co., Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled&#xD;
        study. The purpose of this study is to evaluate the efficacy and safety of the Focused&#xD;
        UltrasoundDevice (FUBA5200) for Fat Reduction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled&#xD;
        study. The purpose of this study is to evaluate the efficacy and safety of the Focused&#xD;
        UltrasoundDevice (FUBA5200) for Fat Reduction.The primary objective of this study is to&#xD;
        evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at&#xD;
        last visit relative to active comparator.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 6, 2022</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">November 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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction in circumference measurement of the abdomen from baseline</measure>
      <time_frame>Week 10</time_frame>
      <description>The primary objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at last visit relative to active comparator (last visit (visit 7)：28 days after the 4th treatment).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction in circumference measurement of the abdomen every visit</measure>
      <time_frame>Day 0、1 and week 2、4、6</time_frame>
      <description>The second objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction of abdomen every visit (visit 2, 3, 4, 5 and 6).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit</measure>
      <time_frame>Week 10</time_frame>
      <description>evaluate the effectiveness of the FUBA5200 System on abdominal subcutaneous fat thickness reduction of abdomen at visit 7.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess subject satisfaction measured with a self-assessment questionnaire (Likert scale)</measure>
      <time_frame>Week 10</time_frame>
      <description>Subject satisfaction with FUBA5200 as determined by the results of a subjects satisfaction questionnaire at the visit 7. Subject satisfaction was designed as a 5-level standard (0-5)，the higher the level, the higher the satisfaction.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Body Sculpting</condition>
    <arm_group>
      <arm_group_label>Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment with the Focused Ultrasound Fat Reduction device (FUBA5200) 4 times in total, once every two weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment with the focused ultrasound fat reduction device (Contour I V3) 4 times in total, once every two weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non Invasive Ultrasound (FUBA5200)</intervention_name>
      <description>the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd</description>
      <arm_group_label>Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non Invasive Ultrasound (Contour I V3)</intervention_name>
      <description>the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.</description>
      <arm_group_label>Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18~55 years;&#xD;
  &#xD;
            2. Abdominal fat thickness of at least 2.0 cm;&#xD;
  &#xD;
            3. Body mass index (BMI) &lt;28.0 kg/m2;&#xD;
  &#xD;
            4. Simple localized obesity with abdominal subcutaneous fat accumulation;&#xD;
  &#xD;
            5. Those who voluntarily participate in this clinical trial and sign informed consent,&#xD;
               agreeing to maintain the same dietary and exercise habits during the study period as&#xD;
               before treatment, and to maintain changes in body weight of no more than ±6%;&#xD;
  &#xD;
            6. For women of childbearing potential with negative serum pregnancy tests at&#xD;
               Screening/baseline;&#xD;
  &#xD;
            7. Those who have not participated in any clinical trials within three months prior to&#xD;
               enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women, breastfeeding women or women at childbearing age who are expected to&#xD;
               become pregnant or who are prone to contraceptive failure;&#xD;
  &#xD;
            2. Subjects with pacemakers, implantable cardiac defibrillators or other electromagnetic&#xD;
               implantable medical systems;&#xD;
  &#xD;
            3. History of underlying medical conditions such as hypertension (blood pressure ≥ 140/90&#xD;
               mmHg), hyperlipidemia, diabetes, hyperthyroidism or hypothyroidism;&#xD;
  &#xD;
            4. Patients who are positive for 4 preoperative infection tests (including anti-human&#xD;
               immunodeficiency virus antibodies, syphilis spirochete-specific antibodies, hepatitis&#xD;
               C virus antibodies, and hepatitis B surface antigen, in which any one of these is&#xD;
               positive);&#xD;
  &#xD;
            5. Patients with autoimmune or connective tissue diseases or malignant tumors;&#xD;
  &#xD;
            6. Those with cardiac, hepatic or renal insufficiency (Alanine aminotransferase or&#xD;
               Aspartate Transaminase &gt; 1.5 times the upper limit of normal; Blood urea nitrogen &gt;&#xD;
               1.5 times the upper limit of normal or Cr &gt; the upper limit of normal; ischemic heart&#xD;
               disease; cardiac valvular disease; congestive heart failure);&#xD;
  &#xD;
            7. Abnormal coagulation, abnormal blood counts, and dyslipidemia (total cholesterol,&#xD;
               triglycerides, or LDL exceeding 20% of the upper limit of the normal range);&#xD;
  &#xD;
            8. History of exposure to high fat-soluble compounds (e.g., pesticides, herbicides, or&#xD;
               drugs known to be stored in fat, except oral contraceptives), use of retinoids within&#xD;
               the last 1 month;&#xD;
  &#xD;
            9. History of lacerations or dermatologic conditions, active dermatologic conditions,&#xD;
               known tendency to form keloids or poor wound healing in the area of treatment; current&#xD;
               infectious lesions in the area of treatment and its immediate vicinity;&#xD;
  &#xD;
           10. Abdominal hernia, diastasis recti or known abdominal aortic aneurysm (abdominal&#xD;
               treatment);&#xD;
  &#xD;
           11. History of fat reduction procedures at the treatment site (e.g., undergoing&#xD;
               liposuction, surgery, use of lipolytic agents, etc.) or history of other surgeries or&#xD;
               presence of implants at the required treatment site and its adjacent areas;&#xD;
  &#xD;
           12. Non-invasive or minimally invasive fat reduction, skin tightening, or lipolysis&#xD;
               treatments such as ultrasound, radiofrequency, etc., on the abdomen within the past 6&#xD;
               months;&#xD;
  &#xD;
           13. Received weight loss treatment methods (including medication, physical therapy and&#xD;
               controlled diet and exercise therapy) within the past 1 month;&#xD;
  &#xD;
           14. Those who are allergic to medical device treatments and excipients and acoustic gel&#xD;
               for this treatments;&#xD;
  &#xD;
           15. Concomitant use with anti-aggregating drugs (non-steroidal anti-inflammatory drugs&#xD;
               NSAIDS, etc.). o) Concomitant use with anticoagulant drugs (Warfarin, etc.);&#xD;
  &#xD;
           16. Subjects with unrealistic expectations of therapeutic efficacy;&#xD;
  &#xD;
           17. Patients with legally defined disabilities (blindness, deafness, dumbness, mental&#xD;
               retardation, physical disability);&#xD;
  &#xD;
           18. Persons with mental disorders;&#xD;
  &#xD;
           19. Patients who are unable or unwilling to comply with the requirements of the study;&#xD;
  &#xD;
           20. Subject is in other conditions deemed unsuitable for the trial by the investigator&#xD;
               judgment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>YuLan Chen</last_name>
      <phone>0755-82418801</phone>
      <email>chenyulan@cms.net.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Anzhen Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>WenZhi Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>HongYu Xue</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital Fudan University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>JinHua Xu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT06017648
  org study id: HJ002-07-001
  nct id: NCT06017648
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled
        study. The purpose of this study is to evaluate the efficacy and safety of the Focused
        UltrasoundDevice (FUBA5200) for Fat Reduction.
  This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled
        study. The purpose of this study is to evaluate the efficacy and safety of the Focused
        UltrasoundDevice (FUBA5200) for Fat Reduction.The primary objective of this study is to
        evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at
        last visit relative to active comparator.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Reduction in circumference measurement of the abdomen from baseline
  time frame: Week 10
  description: The primary objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at last visit relative to active comparator (last visit (visit 7)：28 days after the 4th treatment).
  measure: Reduction in circumference measurement of the abdomen every visit
  time frame: Day 0、1 and week 2、4、6
  description: The second objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction of abdomen every visit (visit 2, 3, 4, 5 and 6).
  measure: Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit
  time frame: Week 10
  description: evaluate the effectiveness of the FUBA5200 System on abdominal subcutaneous fat thickness reduction of abdomen at visit 7.
  measure: Assess subject satisfaction measured with a self-assessment questionnaire (Likert scale)
  time frame: Week 10
  description: Subject satisfaction with FUBA5200 as determined by the results of a subjects satisfaction questionnaire at the visit 7. Subject satisfaction was designed as a 5-level standard (0-5)，the higher the level, the higher the satisfaction.
  arm group label: Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)
  arm group type: Experimental
  description: Treatment with the Focused Ultrasound Fat Reduction device (FUBA5200) 4 times in total, once every two weeks
  arm group label: Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3)
  arm group type: Active Comparator
  description: Treatment with the focused ultrasound fat reduction device (Contour I V3) 4 times in total, once every two weeks
  intervention type: Device
  intervention name: Non Invasive Ultrasound (FUBA5200)
  description: the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd
  arm group label: Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)
  intervention type: Device
  intervention name: Non Invasive Ultrasound (Contour I V3)
  description: the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.
  arm group label: Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: YuLan Chen
  phone: 0755-82418801
  email: chenyulan@cms.net.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor