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Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00607529
Enrollment
99
Registered
2008-02-05
Start date
2007-08-31
Completion date
2010-05-31
Last updated
2010-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Multiple Diseases

Brief summary

This study is being done to see if the Nova Creatinine Meter can give a correct measure of creatinine (a blood test used to measure kidney function) when the blood is taken from a capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory creatinine testing can take up to an hour. Since chemotherapy patients need to have their creatinine measured prior to treatment, this meter could make testing easier and faster.

Interventions

OTHERhand-held POC creatinine analyzer-blood test

This study will require the collection of a finger-puncture capillary blood specimen in addition to one green stoppered heparin containing collection tube. This is taken pre-therapy. The capillary whole blood specimen will be used to perform a creatinine determination on the investigational hand-held creatinine analyzer using special test strips for the analysis.

Sponsors

Nova Biomedical Corporation
CollaboratorINDUSTRY
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Written Informed Consent * Must have a creatinine \> or = to than 3.5 mg/dl

Exclusion criteria

* Patients who are less than 18 years of age

Design outcomes

Primary

MeasureTime frame
The primary outcomes would be, reduced wait time and increased patient satisfaction.conclusion of the study

Secondary

MeasureTime frame
reduced blood lossconclusion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026