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临床试验/NCT04170413
NCT04170413已完成不适用

Feasibility of Using CeVUS During Urodynamic Studies

University of Virginia1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Number of Participants with successful completion of urodynamics

研究概览

简要总结

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

详细描述

Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. Recently, sulfur hexafluoride lipid-type A microspheres (LumasonTM), an ultrasound contrast agent, has been approved in the United States for intravesicular administration in the pediatric population. Contrast enhanced voiding urosonography (CEvUS) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. Given the similarity in procedure between urodynamic studies (UDS) and voiding cystourethrograms, the investigators hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. The investigators plan to conduct a small feasibility study by recruiting a group of 30 patients under the age of 18, who are willing to undergo their normally scheduled UDS in addition to CEvUS. The UDS typically consists of two cycles of bladder filling and voiding; the investigators intend to replace the use of fluoroscopy and iohexol with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. There will not be a formal analysis of data as the investigators are planning to test the feasibility of the procedure rather than gather any quantitative data. The goal of the study is to eventually implement CEvUS instead of fluoroscopy in all urodynamic and voiding studies if it is found to be a reasonable alternative. This will decrease pediatric radiation exposure, which will be especially important in the patients undergoing several studies each year.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Must have had prior urodynamic study at University of Virginia

排除标准

  • Pregnant women
  • Prisoners
  • Subjects with preexisting cardiac conditions (such as heart failure and ventricular arrhythmias)
  • Subjects with a known hypersensitivity to Lumason

研究组 & 干预措施

CeVUS Urodynamic

patients undergoing urodynamic study with CeVUS

干预措施: CeVUS (Drug)

结局指标

主要结局

Number of Participants with successful completion of urodynamics

时间窗: After enrollment of 30 patients, estimated 1 year

All usual information gathered during urodynamics was able to be obtained

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reza Daugherty, MD

Associate Professor of Radiology and Pediatrics

University of Virginia

研究点 (1)

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