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/NCT05994079</url>
    </required_header>
    <id_info>
      <org_study_id>012/003743</org_study_id>
      <nct_id>NCT05994079</nct_id>
    </id_info>
    <brief_title>Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy</brief_title>
    <official_title>Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of the study is to evaluate the therapeutic effect of High intensity focused&#xD;
        ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lax skin is a common consequence of bariatric weight loss, and it may require one or more&#xD;
        plastic interventions.&#xD;
  &#xD;
        This study carried out to investigate the effectiveness of High-intensity focused ultrasound&#xD;
        (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 20, 2022</start_date>
    <completion_date type="Actual">December 20, 2022</completion_date>
    <primary_completion_date type="Actual">November 20, 2022</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment othe change in skin laxity</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By Investigator Global Aesthetic Improvement Scale (IGAIS).&#xD;
  The investigator will take clinical photographs using consistent patient positioning, camera settings (Canon EOS 600D, high-resolution setting, 5760 × 3840 pixels, Canon Inc., Tokyo, Japan), and room lighting.&#xD;
  Baseline and post-treatment photographs will randomly displayed, and evaluated by Investigator Global Aesthetic Improvement Scale (IGAIS) scores will be determined using side-by-side comparisons of pretreatment and post 4 weeks of treatment.&#xD;
  The scale ranges from 0 to 3 as 0 = No change, 1 = Mild improvement, 2 = Moderate improvement, 3 = Significant improvement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment the change in abdominal skin laxity</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>Assessment of abdominal skin laxity by the modified tissue tonometer :&#xD;
  Mark multiple points to be measured. Include an equivalent normal skin point(s).&#xD;
  Apply the MTT baseplate directly to the tissue through the holes in the template. Hold MTT vertically, with bubble of spirit level centered. Ensure no extra downward pressure is applied while resting the device on the tissue.&#xD;
  Record the depression of the plunger in millimeters after 6 seconds. The patient must be able to remain immobile when the MTT is in contact.&#xD;
  Repeat each point three times with at least 2 minutes' &quot;rest&quot; between attempts. Recalibrate the device to zero on a solid surface between each set of measures.&#xD;
  To determine longitudinal change in measures, comparison of averaged score for individual points is appropriate and/or analysis of the change of individual sagging points difference from normal skin control point(s).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">86</enrollment>
    <condition>Skin Laxity</condition>
    <condition>Gastrostomy</condition>
    <arm_group>
      <arm_group_label>high intensity focused ultrasound group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive high intensity focused ultrasound. patients will receive one session; time of session is 40 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>medical topical firming creams group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>High intensity focused ultrasound</intervention_name>
      <description>Parameters:&#xD;
  Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.&#xD;
  Energy per ultrasound pulse ranged from 1.0 to 1.5 J</description>
      <arm_group_label>high intensity focused ultrasound group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>topical firming creams</intervention_name>
      <description>medical topical firming creams</description>
      <arm_group_label>medical topical firming creams group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The subject selection will be according to the following criteria:&#xD;
  &#xD;
            -  Age range between 30-45 years.&#xD;
  &#xD;
            -  Female patients will participate in the study.&#xD;
  &#xD;
            -  All patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate&#xD;
               degree according to skin laxity scale Randomized images were evaluated by three&#xD;
               clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 =&#xD;
               mild, 2 = moderate, 3 = severe).&#xD;
  &#xD;
            -  All patients enrolled to the study will have their informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The potential participants will be excluded if they meet one of the following criteria:&#xD;
  &#xD;
            -  Age more than 45 years or less than 30 years.&#xD;
  &#xD;
            -  Patients have acute viral diseases, acute tuberculosis, mental disorders&#xD;
  &#xD;
            -  Older people with more extensive photo-aging, severe skin laxity.&#xD;
  &#xD;
            -  Open skin lesions at the target area.&#xD;
  &#xD;
            -  Severe or cystic acne.&#xD;
  &#xD;
            -  Metallic implants in the treatment area.&#xD;
  &#xD;
            -  Genetic disease&#xD;
  &#xD;
            -  Skin infectious diseases.&#xD;
  &#xD;
            -  Sociological diseases.&#xD;
  &#xD;
            -  Pregnant.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rania Elhawary</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Outpatient clinic faculty of physical therapy cairo university</name>
        <address>
          <city>Dokki</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Rania Hassan Kamel Abdelkader El-Hawary</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cutis Laxa</mesh_term>
    </condition_browse>
    <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/NCT05994079
  org study id: 012/003743
  nct id: NCT05994079
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the therapeutic effect of High intensity focused
        ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.
  Lax skin is a common consequence of bariatric weight loss, and it may require one or more
        plastic interventions.
  
        This study carried out to investigate the effectiveness of High-intensity focused ultrasound
        (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Assessment othe change in skin laxity
  time frame: at baseline and after 4 weeks of intervention
  description: By Investigator Global Aesthetic Improvement Scale (IGAIS).
  The investigator will take clinical photographs using consistent patient positioning, camera settings (Canon EOS 600D, high-resolution setting, 5760 × 3840 pixels, Canon Inc., Tokyo, Japan), and room lighting.
  Baseline and post-treatment photographs will randomly displayed, and evaluated by Investigator Global Aesthetic Improvement Scale (IGAIS) scores will be determined using side-by-side comparisons of pretreatment and post 4 weeks of treatment.
  The scale ranges from 0 to 3 as 0 = No change, 1 = Mild improvement, 2 = Moderate improvement, 3 = Significant improvement.
  measure: Assessment the change in abdominal skin laxity
  time frame: at baseline and after 4 weeks of intervention
  description: Assessment of abdominal skin laxity by the modified tissue tonometer :
  Mark multiple points to be measured. Include an equivalent normal skin point(s).
  Apply the MTT baseplate directly to the tissue through the holes in the template. Hold MTT vertically, with bubble of spirit level centered. Ensure no extra downward pressure is applied while resting the device on the tissue.
  Record the depression of the plunger in millimeters after 6 seconds. The patient must be able to remain immobile when the MTT is in contact.
  Repeat each point three times with at least 2 minutes' "rest" between attempts. Recalibrate the device to zero on a solid surface between each set of measures.
  To determine longitudinal change in measures, comparison of averaged score for individual points is appropriate and/or analysis of the change of individual sagging points difference from normal skin control point(s).
  arm group label: high intensity focused ultrasound group
  arm group type: Experimental
  description: This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive high intensity focused ultrasound. patients will receive one session; time of session is 40 minutes.
  arm group label: medical topical firming creams group
  arm group type: Active Comparator
  description: This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.
  intervention type: Device
  intervention name: High intensity focused ultrasound
  description: Parameters:
  Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.
  Energy per ultrasound pulse ranged from 1.0 to 1.5 J
  arm group label: high intensity focused ultrasound group
  intervention type: Other
  intervention name: topical firming creams
  description: medical topical firming creams
  arm group label: medical topical firming creams group
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rania Elhawary
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Rania Hassan Kamel Abdelkader El-Hawary
  investigator title: Principal Investigator
  mesh term: Cutis Laxa
  sharing ipd: No