Status:
UNKNOWN
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP
Lead Sponsor:
OrSense, Ltd.
Conditions:
Anemia
Eligibility:
All Genders
18-95 years
Brief 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 comp...
Detailed 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 i...
Eligibility Criteria
Inclusion
- Participants aged 18 years and over
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01915953
Start Date
February 1 2011
End Date
December 1 2013
Last Update
August 6 2013
Active Locations (1)
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1
Assaf Harofeh Medical Center
Beer Yaacov, Israel, Israel, 70300