跳至主要内容
临床试验/NCT03286231
NCT03286231已完成不适用

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.

University of South Florida1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Mean difference of position of the gluteal venous vasculature in relation to the skin

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

结局指标

主要结局

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

时间窗: at CT scan visit

Between the Prone position and the Jackknife position

次要结局

  • Mean difference of vessel diameter of the gluteal venous vasculature(at CT scan visit)
  • Mean difference of the danger zone(at CT scan visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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