NCT02516319

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

July 21, 2015

Last Update Submit

January 14, 2016

Conditions

Hepatic Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Other Outcomes (5)

  • Adverse-event recording

    Two hours post ICG dose

  • Physical Examination

    Up to one hour post ICG dose

  • Blood pressure

    Up to one hour post ICG dose

  • +2 more other outcomes

Study Arms (2)

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.

Drug: ICG Dye

Liver Funtion Test Dye Detection Monitor

EXPERIMENTAL

All cohorts receive continuous LFT monitoring post ICG injection.

Drug: ICG Dye

Interventions

ICG DyeDRUG
Liver Funtion Test Dye Detection MonitorSerial Blood Draws

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, aged 18 to 75 years, inclusive
  • Informed consent documentation understood and signed.

You may not qualify if:

  • Known allergy or sensitivity to the ICG or to iodide contrast dye
  • Pregnant women or those nursing babies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Michael W Jopling, M.D

    Cardiox Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

August 5, 2015

Study Start

September 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 15, 2016

Record last verified: 2016-01