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Trial record 1 of 1 for:    28369293 [PUBMED-IDS]
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Anti-FLEX: Flexed Levering of Gluteal Vessels

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ClinicalTrials.gov Identifier: NCT03286231
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone and jackknife positions.

Condition or disease Intervention/treatment
Healthy Diagnostic Test: CT imaging

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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 "Jack-knife" Position, Danger Zone.
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : February 2019

Group/Cohort Intervention/treatment
Healthy volunteers
Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions
Diagnostic Test: CT imaging
Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions




Primary Outcome Measures :
  1. Mean difference of position of the gluteal venous vasculature in relation to the skin [ Time Frame: at CT scan visit ]
    Between the Prone position and the Jackknife position


Secondary Outcome Measures :
  1. Mean difference of vessel diameter of the gluteal venous vasculature [ Time Frame: at CT scan visit ]
    Between the Prone position and the Jackknife position

  2. Mean difference of the danger zone [ Time Frame: at CT scan visit ]
    Between the Prone position and the Jackknife position



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions
Criteria

Inclusion Criteria:

  • Females age 20 - 50 years
  • BMI between 20 - 35 kg/m2
  • Willingness and ability to provide written informed consent
  • Willingness and ability to comply with all study procedures
  • Interested or planning to have a gluteal augmentation

Exclusion Criteria:

  • Males
  • Females age < 20 or >= 51 years
  • BMI between < 20 or > 35 kg/m2
  • Prior gluteal augmentation surgery
  • Any prior gluteal soft tissue filler
  • Known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium
  • Documented history of chronic kidney disease that contraindicates the use of contrast dye
  • Pregnant
  • Currently breast-feeding
  • Any reason (in addition to those listed above) that, in the opinion of the principal investigator, precludes full participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286231


Contacts
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Contact: Thanh Tran, MPH 813-844-8544 thanhtran@health.usf.edu
Contact: Rachel Karlnoski, PhD 813-844-4133 rkarlnos@health.usf.edu

Locations
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United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Contact: Thanh Tran, MPH    813-844-8544    thanhtran@health.usf.edu   
Principal Investigator: Connor Barnes, MD         
Sub-Investigator: David Smith, MD         
Sub-Investigator: Rajendra Kedar, MD         
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Connor Barnes, MD University of South Florida

Publications of Results:
Other Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03286231     History of Changes
Other Study ID Numbers: Pro00031729
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of South Florida:
gluteal venous vasculature
prone position
jackknife position