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Completed

NCT Number: NCT03286231

Anti-FLEX: Flexed Levering of Gluteal Vessels

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

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT imaging

Diagnostic Test

Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Sep 18, 2017
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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