qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points
研究概览
简要总结
The purpose of this research is to evaluate a new technique, quantitative digital subtraction angiography (qDSA), to measure blood flow during liver embolization procedures. Liver embolization is a way of treating liver tumors by blocking blood flow to it. The qDSA technique could help doctors ensure the blood flow to the tumor is decreased by the right amount by calculating blood flow before, during, and after the procedure. Up to 20 participants will be enrolled for 1 study visit and data collection for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule
排除标准
- •Pregnancy or breastfeeding
- •Patients with an acute kidney injury or stage IV or V chronic kidney disease (Cr greater than 2.4 or estimated glomerular filtration rate (eGFR) less than 30), unless anuric and on dialysis without expected return of renal function.
- •Patients with an iodinated contrast allergy who cannot be adequately premedicated to receive contrast as part of the embolization procedure.
- •Patients with a physical or psychological condition that would impair study participation.
- •The patient is judged unsuitable for study participation by the Investigator for any other reason
研究组 & 干预措施
Participants Undergoing TAE of the Liver
干预措施: qDSA Blood Flow Measurement (Device)
结局指标
主要结局
Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points
时间窗: data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months)
次要结局
- Velocity measurements made on qDSA vs transabdominal Doppler US(measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months))
- Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from baseline(data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months))
- Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Number of procedures retrospectively judged to end early(data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months))