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

This study has been completed.
Sponsor:
Collaborator:
Nova Biomedical Corporation
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00607529
First received: January 22, 2008
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Cancer
Other: hand-held POC creatinine analyzer-blood test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The primary outcomes would be, reduced wait time and increased patient satisfaction. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduced blood loss [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood


Enrollment: 99
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients having a creatinine drawn
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MSKCC patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607529

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Nova Biomedical Corporation
Investigators
Principal Investigator: Martin Fleisher, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Martin Fleisher, PhD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00607529     History of Changes
Other Study ID Numbers: 07-023
Study First Received: January 22, 2008
Last Updated: June 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Multiple Diseases

ClinicalTrials.gov processed this record on September 22, 2014