<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/NCT03286231</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00031729</org_study_id>
    <nct_id>NCT03286231</nct_id>
  </id_info>
  <brief_title>Anti-FLEX: Flexed Levering of Gluteal Vessels</brief_title>
  <official_title>Anti-FLEX: Flexed Levering of Gluteal Vessels on OR Table May Lead to Extreme Danger During Gluteal Augmentation With Lipoaspirate, a Radio-graphically Studied Position of Superior and Inferior Gluteal Vessels During Flexion of OR Table or &quot;Jack-knife&quot; Position, Danger Zone.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</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>
      The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone&#xD;
      and jackknife positions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective collection of contrast-enhanced CT images of healthy female volunteers&#xD;
      in prone and jackknife positions in order to determine if position impacts gluteal venous&#xD;
      vasculature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Actual">January 13, 2020</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference of position of the gluteal venous vasculature in relation to the skin</measure>
    <time_frame>at CT scan visit</time_frame>
    <description>Between the Prone position and the Jackknife position</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference of vessel diameter of the gluteal venous vasculature</measure>
    <time_frame>at CT scan visit</time_frame>
    <description>Between the Prone position and the Jackknife position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference of the danger zone</measure>
    <time_frame>at CT scan visit</time_frame>
    <description>Between the Prone position and the Jackknife position</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT imaging</intervention_name>
    <description>Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous&#xD;
        vasculature in the prone and jackknife positions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females age 20 - 50 years&#xD;
&#xD;
          -  BMI between 20 - 35 kg/m2&#xD;
&#xD;
          -  Willingness and ability to provide written informed consent&#xD;
&#xD;
          -  Willingness and ability to comply with all study procedures&#xD;
&#xD;
          -  Interested or planning to have a gluteal augmentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Females age &lt; 20 or &gt;= 51 years&#xD;
&#xD;
          -  BMI between &lt; 20 or &gt; 35 kg/m2&#xD;
&#xD;
          -  Prior gluteal augmentation surgery&#xD;
&#xD;
          -  Any prior gluteal soft tissue filler&#xD;
&#xD;
          -  Known or suspected history of immediate or delayed hypersensitivity (including but not&#xD;
             limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and&#xD;
             bronchospasm) to iodine or any iodinated contrast medium&#xD;
&#xD;
          -  Documented history of chronic kidney disease that contraindicates the use of contrast&#xD;
             dye&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Currently breast-feeding&#xD;
&#xD;
          -  Any reason (in addition to those listed above) that, in the opinion of the principal&#xD;
             investigator, precludes full participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females only</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connor Barnes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Illouz YG. The fat cell &quot;graft&quot;: a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.</citation>
    <PMID>3725947</PMID>
  </reference>
  <reference>
    <citation>Hsu VM, Stransky CA, Bucky LP, Percec I. Fat grafting's past, present, and future: why adipose tissue is emerging as a critical link to the advancement of regenerative medicine. Aesthet Surg J. 2012 Sep;32(7):892-9. doi: 10.1177/1090820X12455658.</citation>
    <PMID>22942117</PMID>
  </reference>
  <reference>
    <citation>Cardenas-Camarena L, Arenas-Quintana R, Robles-Cervantes JA. Buttocks fat grafting: 14 years of evolution and experience. Plast Reconstr Surg. 2011 Aug;128(2):545-555. doi: 10.1097/PRS.0b013e31821b640b.</citation>
    <PMID>21788847</PMID>
  </reference>
  <reference>
    <citation>Toledo LS. Gluteal augmentation with fat grafting: the Brazilian buttock technique: 30 years' experience. Clin Plast Surg. 2015 Apr;42(2):253-61. doi: 10.1016/j.cps.2014.12.004.</citation>
    <PMID>25827567</PMID>
  </reference>
  <reference>
    <citation>LINCOLN JR, SAWYER HP Jr. Complications related to body positions during surgical procedures. Anesthesiology. 1961 Sep-Oct;22:800-9. doi: 10.1097/00000542-196109000-00014. No abstract available.</citation>
    <PMID>14465376</PMID>
  </reference>
  <reference>
    <citation>Astarita DC, Scheinin LA, Sathyavagiswaran L. Fat transfer and fatal macroembolization. J Forensic Sci. 2015 Mar;60(2):509-10. doi: 10.1111/1556-4029.12549. Epub 2015 Feb 4.</citation>
    <PMID>25653075</PMID>
  </reference>
  <results_reference>
    <citation>Mofid MM, Teitelbaum S, Suissa D, Ramirez-Montanana A, Astarita DC, Mendieta C, Singer R. Report on Mortality from Gluteal Fat Grafting: Recommendations from the ASERF Task Force. Aesthet Surg J. 2017 Jul 1;37(7):796-806. doi: 10.1093/asj/sjx004.</citation>
    <PMID>28369293</PMID>
  </results_reference>
  <results_reference>
    <citation>Klein SM, Prantl L, Geis S, Eisenmann-Klein M, Dolderer J, Felthaus O, Loibl M, Heine N. Pressure monitoring during lipofilling procedures. Clin Hemorheol Microcirc. 2014;58(1):9-17. doi: 10.3233/CH-141872.</citation>
    <PMID>25227189</PMID>
  </results_reference>
  <results_reference>
    <citation>Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.</citation>
    <PMID>2343107</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gluteal venous vasculature</keyword>
  <keyword>prone position</keyword>
  <keyword>jackknife position</keyword>
  <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/NCT03286231
org study id: Pro00031729
nct id: NCT03286231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone
      and jackknife positions.
This is a prospective collection of contrast-enhanced CT images of healthy female volunteers
      in prone and jackknife positions in order to determine if position impacts gluteal venous
      vasculature.
observational model: Cohort
time perspective: Prospective
measure: Mean difference of position of the gluteal venous vasculature in relation to the skin
time frame: at CT scan visit
description: Between the Prone position and the Jackknife position
measure: Mean difference of vessel diameter of the gluteal venous vasculature
time frame: at CT scan visit
description: Between the Prone position and the Jackknife position
measure: Mean difference of the danger zone
time frame: at CT scan visit
description: Between the Prone position and the Jackknife position
arm group label: Healthy volunteers
description: Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions
intervention type: Diagnostic Test
intervention name: CT imaging
description: Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions
arm group label: Healthy volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Females only
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Connor Barnes, MD
role: Principal Investigator
affiliation: University of South Florida
facility: 
country: United States
citation: Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.
PMID: 3725947
citation: Hsu VM, Stransky CA, Bucky LP, Percec I. Fat grafting's past, present, and future: why adipose tissue is emerging as a critical link to the advancement of regenerative medicine. Aesthet Surg J. 2012 Sep;32(7):892-9. doi: 10.1177/1090820X12455658.
PMID: 22942117
citation: Cardenas-Camarena L, Arenas-Quintana R, Robles-Cervantes JA. Buttocks fat grafting: 14 years of evolution and experience. Plast Reconstr Surg. 2011 Aug;128(2):545-555. doi: 10.1097/PRS.0b013e31821b640b.
PMID: 21788847
citation: Toledo LS. Gluteal augmentation with fat grafting: the Brazilian buttock technique: 30 years' experience. Clin Plast Surg. 2015 Apr;42(2):253-61. doi: 10.1016/j.cps.2014.12.004.
PMID: 25827567
citation: LINCOLN JR, SAWYER HP Jr. Complications related to body positions during surgical procedures. Anesthesiology. 1961 Sep-Oct;22:800-9. doi: 10.1097/00000542-196109000-00014. No abstract available.
PMID: 14465376
citation: Astarita DC, Scheinin LA, Sathyavagiswaran L. Fat transfer and fatal macroembolization. J Forensic Sci. 2015 Mar;60(2):509-10. doi: 10.1111/1556-4029.12549. Epub 2015 Feb 4.
PMID: 25653075
citation: Mofid MM, Teitelbaum S, Suissa D, Ramirez-Montanana A, Astarita DC, Mendieta C, Singer R. Report on Mortality from Gluteal Fat Grafting: Recommendations from the ASERF Task Force. Aesthet Surg J. 2017 Jul 1;37(7):796-806. doi: 10.1093/asj/sjx004.
PMID: 28369293
citation: Klein SM, Prantl L, Geis S, Eisenmann-Klein M, Dolderer J, Felthaus O, Loibl M, Heine N. Pressure monitoring during lipofilling procedures. Clin Hemorheol Microcirc. 2014;58(1):9-17. doi: 10.3233/CH-141872.
PMID: 25227189
citation: Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.
PMID: 2343107
responsible party type: Sponsor
sharing ipd: No