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临床试验/NCT01450969
NCT01450969已完成不适用

Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

Baptist Health South Florida1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Radiation attenuation in percentage (%) and in absolute terms (μSv/min)

研究概览

简要总结

The PREFER Trial primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.

详细描述

The PREFER Trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms. The secondary objective of the study is to measure and compare the amount of radiation that interventional radiologists are exposed to per case in an interventional suite setting using FDA approved XPF thyroid collars or standard 0.5 mm Pb equivalent thyroid collars. The third objective is to assess the operator comfort wearing the XPF protection devices. In order to achieve these objectives, measurements will be performed in 60 consecutive endovascular procedures requiring C-arm fluoroscopy performed at BCVI. Participants will be asked to wear an XPF cap (weighing approximately 100 grams) in every study procedure. Furthermore, a prospective randomization will be performed, assigning participants to wear their own standard 0.5 mm Pb equivalent thyroid collar or to wear the FDA approved XPF thyroid collar. Radiation exposure will be monitored with 4 radiation detectors (TLDs, 2 attached to the cap, 2 attached to the collar) which the participant is required to wear. After each procedure the participant will be asked to rate the comfort of wearing the devices on a scale from 1 to 100.

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

入选标准

  • Interventional Radiologists practicing in Baptist Cardiac & Vascular Institute
  • consecutive endovascular procedure requiring C-arm fluoroscopy

排除标准

  • Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.

结局指标

主要结局

Radiation attenuation in percentage (%) and in absolute terms (μSv/min)

时间窗: The attenuation is assessed directly after each procedure (day 1)

The null hypothesis is that the XPF thyroid collar is inferior to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission. The alternative hypothesis is that the XPF thyroid collar is non-inferior to the standard thyroid collar. If there is truly no difference between standard and XPF thyroid collars, then 60 patients are required to be 95% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -0.7% transmission rate and -0.013 μSv/min.

次要结局

  • Wearing comfort of the XPF cap and collar on a scale from 0-100.((day 1) Operators are asked directly after each procedure to rate the wearing comfort)

研究者

发起方
Baptist Health South Florida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raul Herrera, MD

Director, Division of Clinical Research & Outcomes

Baptist Health South Florida

研究点 (1)

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