drugset / Trial / NCT02552901
Cardiox Liver Function Test Pivotal Trial
Non-randomizedSingle-groupOpen-labelDiagnostic
Summary
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR.
Timeline
- Start
- 2015-11
- Primary completion
- 2016-05
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ICG | Diagnostic / imaging agent | 0.1 mg/kg | Intravenous |
| Subject | ICG | Diagnostic / imaging agent | 0.5 mg/kg | Intravenous |