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CompletedNCT03286231Updated Feb 28, 2020

Anti-FLEX: Flexed Levering of Gluteal Vessels

An observational study in Healthy, sponsored by University of South Florida. Completed at 1 site in United States. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by University of South Florida · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • gluteal venous vasculature
  • prone position
  • jackknife position
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testCT imaging

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

05

What researchers measure

Primary outcomes

  1. Mean difference of position of the gluteal venous vasculature in relation to the skin

    Between the Prone position and the Jackknife position

    Time frame: at CT scan visit

Secondary outcomes

  1. Mean difference of vessel diameter of the gluteal venous vasculature

    Between the Prone position and the Jackknife position

    Time frame: at CT scan visit

  2. Mean difference of the danger zone

    Between the Prone position and the Jackknife position

    Time frame: at CT scan visit

06

Study locations

1 site
  • Tampa General Hospital
    Tampa, Florida 33606, United States
07

References and documents

Publications

  • Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available. PubMed 3725947 ↗
  • 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. PubMed 22942117 ↗
  • 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. PubMed 21788847 ↗
  • 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. PubMed 25827567 ↗
  • 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. PubMed 14465376 ↗
  • 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. PubMed 25653075 ↗
  • 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. PubMed 28369293 ↗
  • 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. PubMed 25227189 ↗
  • 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. PubMed 2343107 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03286231
Lead sponsor
University of South Florida
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
May 3, 2018
Primary completion
Nov 21, 2018
Completion
Jan 13, 2020
Last update
Feb 28, 2020

Study contacts

Connor Barnes, MD
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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