Study Results
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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COMPLETED
11 participants
OBSERVATIONAL
2018-05-03
2020-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
50 Years
FEMALE
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Pro00031729
Identifier Type: -
Identifier Source: org_study_id
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