Overview

This trial is active, not recruiting.

Condition anemia
Sponsor OrSense, Ltd.
Start date February 2011
End date October 2013
Trial size 500 participants
Trial identifier NCT01915953, QD04.5.1-15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Measuring Hb valuse on anemia patients

Primary Outcomes

Measure
compre the Hb values from the NBM200 series gainst the Hb from the lab blood analyser on Hematology pateints
time frame: 1 day

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

Inclusion Criteria: - Participants aged 18 years and over Exclusion Criteria: - Participants under the age of 18 years - Patients with significant deformity, degenerative changes or oedema of the fingers or hand - Patients with localized infection, ulceration or skin breaks involving the fingers - Patients with vascular disease or Raynaud's phenomenon affecting the fingers (vasospasm) - Participants who are unable to give informed written consent

Additional Information

Official title A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP
Principal investigator Abraham Korenberg, MD
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 complete blood count or Hb blood analyzers.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by OrSense, Ltd..