Anti-FLEX: Flexed Levering of Gluteal Vessels

NCT ID: NCT03286231

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-01-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

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

CT imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CT imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Connor Barnes, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

References

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Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.

Reference Type BACKGROUND
PMID: 3725947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22942117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21788847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25827567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14465376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25653075 (View on PubMed)

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.

Reference Type RESULT
PMID: 28369293 (View on PubMed)

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.

Reference Type RESULT
PMID: 25227189 (View on PubMed)

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.

Reference Type RESULT
PMID: 2343107 (View on PubMed)

Other Identifiers

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Pro00031729

Identifier Type: -

Identifier Source: org_study_id

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