Anti-FLEX: Flexed Levering of Gluteal Vessels

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: CT imaging

• Registration Number: NCT03286231
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2018-05-03
• Primary Completion: 2018-11-21
• Study Completion: 2020-01-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	CT imaging	Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions

Primary Outcome Measures

Name	Time	Method
Mean difference of position of the gluteal venous vasculature in relation to the skin	at CT scan visit	Between the Prone position and the Jackknife position

Secondary Outcome Measures

Name	Time	Method
Mean difference of vessel diameter of the gluteal venous vasculature	at CT scan visit	Between the Prone position and the Jackknife position
Mean difference of the danger zone	at CT scan visit	Between the Prone position and the Jackknife position

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States