<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/NCT04406935</url>
  </required_header>
  <id_info>
    <org_study_id>NuEra Tight-19-01</org_study_id>
    <nct_id>NCT04406935</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction</brief_title>
  <official_title>Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lumenis Be Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lumenis Be 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>
      Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential&#xD;
      reduction in the abdominal region within three treatment group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential&#xD;
      reduction in the abdominal region within three treatment group. each group has a different&#xD;
      radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction&#xD;
      in abdominal circumferential after treatment and at 12 week post last treatment within each&#xD;
      treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</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>
    <intervention_model_description>This is a Multi-arm, prospective, multi-center, baseline-controlled study, designed to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction of the abdomen area at three different frequencies.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in abdominal circumference</measure>
    <time_frame>one month</time_frame>
    <description>Change in abdominal circumference in cm</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Circumferential Reduction</condition>
  <arm_group>
    <arm_group_label>475 KHz</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NuEra device treatment using 475 KHz</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 MHz</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 2: NuEra device treatment using 1 MHz</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 MHz</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NuEra device treatment using 2 MHz</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>treatment with the study device (NuEra)</intervention_name>
    <description>Multi-arm, prospective, multi-center, baseline-controlled study:&#xD;
Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz</description>
    <arm_group_label>1 MHz</arm_group_label>
    <arm_group_label>2 MHz</arm_group_label>
    <arm_group_label>475 KHz</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Male or Female, 18 to 65 years of age 2. Has visible fat bulges on the abdomen 3.&#xD;
             Has a Body Mass Index (BMI) ≤ 30 4. Non-smoking for at least 6 months and willing to&#xD;
             refrain from smoking for the duration of the study.&#xD;
&#xD;
             5. Subject must agree to not undergo any other procedure(s) in the abdominal region&#xD;
             during the study period.&#xD;
&#xD;
             6. Subject who is willing to refrain from a change in diet/ exercise/medication&#xD;
             regimen for the entire course of the study and to maintain his/her weight during the&#xD;
             study within 5% of baseline weight measurement.&#xD;
&#xD;
             7. Subject must agree to adhere to the follow-up schedule and study instructions.&#xD;
&#xD;
             8. Subject must be able to read, understand and sign the Informed Consent Form. 9.&#xD;
             Willing to have digital photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentation, educational or marketing purposes.&#xD;
&#xD;
             10. If the subject is a female and not pregnant or lactating, she must be either&#xD;
             post-menopausal, surgically sterilized or using a medically acceptable form of birth&#xD;
             control at least 3 months prior to enrolment (i.e oral contraceptives, contraceptive&#xD;
             implant, barrier methods with spermicide or abstinence) and during the entire course&#xD;
             of the study, and no plans to become pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject had any type of prior cosmetic treatment to the target area within 12 months&#xD;
             of study participation e.g., radiofrequency, cryolipolysis or light-based treatments.&#xD;
&#xD;
          2. Subject had any prior invasive cosmetic surgery to the target area, such as&#xD;
             liposuction&#xD;
&#xD;
          3. Subject has scar tissue in and around the treatment area (i.e. cesarean-section or&#xD;
             traumatic injury scar)&#xD;
&#xD;
          4. Subject has tattoo(s) that extend over a substantial portion of the treatment area&#xD;
&#xD;
          5. Subject is currently taking medications or supplements for weight-loss or metabolism&#xD;
             support/enhancement or has a history of taking such medications or supplements within&#xD;
             3 months.&#xD;
&#xD;
          6. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve&#xD;
             stimulator implant, cochlear implant or any other electronically, magnetically or&#xD;
             mechanically activated implant.&#xD;
&#xD;
          7. Has metal implant(s) within the body, such as surgical clips, plates and screws,&#xD;
             intrauterine device (IUD), artificial heart valves or artificial joints.&#xD;
&#xD;
          8. History of diseases stimulated by heat, such as recurrent herpes zoster in the&#xD;
             treatment area, unless treatment is conducted following a prophylactic regimen.&#xD;
&#xD;
          9. History of any disease or condition that could impair wound healing.&#xD;
&#xD;
         10. Infection, dermatitis, rash or other skin abnormality in the target area.&#xD;
&#xD;
         11. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing&#xD;
&#xD;
         12. History of hypertension, ischemic heart disease, valvular heart disease, congestive&#xD;
             heart failure, and abdominal aortic aneurysm&#xD;
&#xD;
         13. Significant concurrent illness, such as diabetes mellitus, hyperlipidemia, liver&#xD;
             disease, HIV positive, blood coagulopathy or excessive bleeding, autoimmune or&#xD;
             connective tissue disease, cardiovascular disease, peripheral vascular disease or&#xD;
             pertinent neurological disorders.&#xD;
&#xD;
         14. History of skin disease in the treatment area or known epidermal or dermal disorders&#xD;
             (particularly if involving collagen or microvascularity)&#xD;
&#xD;
         15. Severe skin laxity in the treatment area&#xD;
&#xD;
         16. Extensive collection of visceral adipose tissue or abdominal wall diastasis or hernia&#xD;
             on physical examination&#xD;
&#xD;
         17. Obesity ≥30 BMI&#xD;
&#xD;
         18. Diagnosed or documented immune system disorders.&#xD;
&#xD;
         19. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or&#xD;
             history of treatment in the target area within 3 months of study participation.&#xD;
&#xD;
         20. Participation in a clinical trial of another device or drug within 6 months of study&#xD;
             participation, or during the study period.&#xD;
&#xD;
         21. Pregnant or currently breastfeeding.&#xD;
&#xD;
         22. As per the Investigator's discretion, any physical or mental condition which might&#xD;
             make it unsafe for the subject to participate in this study.&#xD;
&#xD;
         23. Known allergy to general and/or topical anesthetic&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Skincare Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology and Laser Surgery Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406935
org study id: NuEra Tight-19-01
nct id: NCT04406935
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential
      reduction in the abdominal region within three treatment group
The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential
      reduction in the abdominal region within three treatment group. each group has a different
      radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction
      in abdominal circumferential after treatment and at 12 week post last treatment within each
      treatment group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a Multi-arm, prospective, multi-center, baseline-controlled study, designed to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction of the abdomen area at three different frequencies.
primary purpose: Other
masking: None (Open Label)
measure: Reduction in abdominal circumference
time frame: one month
description: Change in abdominal circumference in cm
arm group label: 475 KHz
arm group type: Active Comparator
description: NuEra device treatment using 475 KHz
arm group label: 1 MHz
arm group type: Active Comparator
description: Arm 2: NuEra device treatment using 1 MHz
arm group label: 2 MHz
arm group type: Active Comparator
description: NuEra device treatment using 2 MHz
intervention type: Device
intervention name: treatment with the study device (NuEra)
description: Multi-arm, prospective, multi-center, baseline-controlled study:
Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz
arm group label: 1 MHz
arm group label: 2 MHz
arm group label: 475 KHz
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided