FDS-0004 Cardiox Shunt Detection Technology Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 13
- 主要终点
- To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS
研究概览
简要总结
The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Eighteen (18) years of age or older
- •Informed consent documentation understood and signed
- •Planned or completed TEE study within the last 12 months
排除标准
- •Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to Iodide Contrast Dye or Iodides
- •Pregnant women or nursing mothers
- •Subject unable or unwilling to understand and sign the informed consent
- •Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of post screening
- •Subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine > 2.0 or subjects currently being followed by a nephrologist
结局指标
主要结局
To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS
时间窗: 1 day
To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS
时间窗: 1 day
次要结局
- To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt(1 day)