<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/NCT03270150</url>
  </required_header>
  <id_info>
    <org_study_id>BTL-899L</org_study_id>
    <nct_id>NCT03270150</nct_id>
  </id_info>
  <brief_title>Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen</brief_title>
  <official_title>Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BTL Industries Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BTL Industries Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective open-label single-arm study that includes three treatment&#xD;
      procedures and four follow-up visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the clinical efficacy and safety of the BTL-899 device for&#xD;
      non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective&#xD;
      open-label single-arm study. The subjects will be enrolled and assigned into a single study&#xD;
      group. Subjects will complete three (3) treatment visits and will be invited to four (4)&#xD;
      follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is&#xD;
      the optional one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">October 3, 2018</completion_date>
  <primary_completion_date type="Actual">September 19, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit</measure>
    <time_frame>4 months</time_frame>
    <description>Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>7 months</time_frame>
    <description>The occurrence of adverse events will be followed throughout the whole study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators</measure>
    <time_frame>4 months</time_frame>
    <description>Evaluation of photographs before and after the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the BTL-899 treatment for abdomen circumference reduction</measure>
    <time_frame>4 months</time_frame>
    <description>Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound imaging</measure>
    <time_frame>4 months</time_frame>
    <description>Evaluation of ultrasound images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's satisfaction with study treatment</measure>
    <time_frame>4 months</time_frame>
    <description>Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy comfort during the study treatment.</measure>
    <time_frame>1 month</time_frame>
    <description>Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Improvement of Abdomen Appearance</condition>
  <arm_group>
    <arm_group_label>BTL-899 Therapy Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BTL-899 therapy, 3 therapies</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BTL-899</intervention_name>
    <description>BTL-899</description>
    <arm_group_label>BTL-899 Therapy Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 21 years&#xD;
&#xD;
          -  Voluntarily signed informed consent form&#xD;
&#xD;
          -  BMI ≤ 35 kg/m2&#xD;
&#xD;
          -  Women of child-bearing potential are required to use birth control measures during the&#xD;
             whole duration of the study&#xD;
&#xD;
          -  Subjects willing and able to abstain from partaking in any treatments other than the&#xD;
             study procedure to promote body contouring during study participation&#xD;
&#xD;
          -  Subjects willing and able to maintain his/her regular (pre-procedure) diet and&#xD;
             exercise regimen without effecting significant change in either direction during study&#xD;
             participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac pacemakers&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
&#xD;
          -  Implanted defibrillators, implanted neurostimulators&#xD;
&#xD;
          -  Electronic implants&#xD;
&#xD;
          -  Disturbance of temperature or pain perception&#xD;
&#xD;
          -  Pulmonary insufficiency&#xD;
&#xD;
          -  Metal implants&#xD;
&#xD;
          -  Drug pumps&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Hemorrhagic conditions&#xD;
&#xD;
          -  Septic conditions and empyema&#xD;
&#xD;
          -  Acute inflammations&#xD;
&#xD;
          -  Systemic or local infection such as osteomyelitis and tuberculosis&#xD;
&#xD;
          -  Contageous skin disease&#xD;
&#xD;
          -  Elevated body temperature&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Injured or otherwise impaired muscles&#xD;
&#xD;
          -  Scars, open lesions and wounds at the treatment area&#xD;
&#xD;
          -  Basedow's disease&#xD;
&#xD;
          -  Previous liposuction in the treatment area in the last six months&#xD;
&#xD;
          -  Abdominal wall diastasis&#xD;
&#xD;
          -  Unstable weight within the last 6 months&#xD;
&#xD;
          -  Previous body contouring treatments in the abdomen area in the last three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aesthe Clinic</name>
      <address>
        <city>Sofia</city>
        <zip>1700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03270150
org study id: BTL-899L
nct id: NCT03270150
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study is a prospective open-label single-arm study that includes three treatment
      procedures and four follow-up visits.
This study will evaluate the clinical efficacy and safety of the BTL-899 device for
      non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective
      open-label single-arm study. The subjects will be enrolled and assigned into a single study
      group. Subjects will complete three (3) treatment visits and will be invited to four (4)
      follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is
      the optional one.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
time frame: 4 months
description: Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
measure: Occurrence of adverse events
time frame: 7 months
description: The occurrence of adverse events will be followed throughout the whole study.
measure: Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators
time frame: 4 months
description: Evaluation of photographs before and after the treatment.
measure: Efficacy of the BTL-899 treatment for abdomen circumference reduction
time frame: 4 months
description: Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.
measure: Ultrasound imaging
time frame: 4 months
description: Evaluation of ultrasound images.
measure: Subject's satisfaction with study treatment
time frame: 4 months
description: Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
measure: Therapy comfort during the study treatment.
time frame: 1 month
description: Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
arm group label: BTL-899 Therapy Arm
arm group type: Experimental
description: BTL-899 therapy, 3 therapies
intervention type: Device
intervention name: BTL-899
description: BTL-899
arm group label: BTL-899 Therapy Arm
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Bulgaria
responsible party type: Sponsor
sharing ipd: No