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NCT00607529 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00607529
Other study ID # 07-023
Secondary ID
Status Completed
Phase N/A
First received January 22, 2008
Last updated June 3, 2010
Start date August 2007
Est. completion date May 2010

Study information
Verified date June 2010
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• hand-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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Nova Biomedical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcomes would be, reduced wait time and increased patient satisfaction. conclusion of the study No
Secondary reduced blood loss conclusion of the study No
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