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Business decision to discontinue product development.
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The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.
Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serial Blood Draws | Active Comparator | Cohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection. |
|
| Liver Funtion Test Dye Detection Monitor | Experimental | All cohorts receive continuous LFT monitoring post ICG injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG Dye | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICG dye detection using the LFT system compared to serial blood sampling ethods. | Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods. | 20 minutes post ICG dose |
| Measure | Description | Time Frame |
|---|---|---|
| ICG fluorescence detection at the scaphoid fossa of the ears | 20 minutes post ICG dose | |
| Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time. | 20 minutes post ICG dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse-event recording | Two hours post ICG dose | |
| Physical Examination | Up to one hour post ICG dose | |
| Blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Jopling, M.D | Cardiox Corporation | Principal Investigator |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Up to one hour post ICG dose |
| Heart rate | Up to one hour post ICG dose |
| Respiration | Up to one hour post ICG dose |