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Completed

NCT Number: NCT00607529

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hand-held POC creatinine analyzer-blood test

Other

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.

Primary outcomes

  1. The primary outcomes would be, reduced wait time and increased patient satisfaction.

    Time frame: conclusion of the study

Secondary outcomes

  1. reduced blood loss

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Nova Biomedical Corporation

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2008
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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