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Clinical Trial Summary

The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.


Clinical Trial Description

Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated CBC or Hb blood analyzers. ;


Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01917851
Study type Observational [Patient Registry]
Source OrSense, Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date April 2011
Completion date December 2013

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