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Cardiox Liver Function Test Pivotal Trial

NCT02552901 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

  • Hepatic Failure
  • Liver Failure

Interventions

DRUG

0.1 mg/kg ICG Dose

least efficacious dose

DRUG

0.5 mg/kg ICG dose

per package insert

Sponsors & Collaborators

  • Cardiox Corporation

    lead INDUSTRY

Principal Investigators

  • Michael Jopling, MD · Medical Director, Cardiox Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552901 on ClinicalTrials.gov