Status:
UNKNOWN
Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients
Lead Sponsor:
OrSense, Ltd.
Conditions:
Anemia
Eligibility:
FEMALE
18-55 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
- Female volunteers aged 18 years and over.
- Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.
Exclusion
- Participants under the age of 18 years
- Significant deformity, degenerative changes or edema of the thumb or index fingers
- Localized infection, ulceration or skin breaks involving the fingers
- Low peripheral body temperature (tissue perfusion) \<36.0˚C
- Vascular disease or Raynaud's phenomenon affecting the fingers
- Participants who are unable to give informed written consent
Key Trial Info
Start Date :
April 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01917851
Start Date
April 1 2011
End Date
December 1 2013
Last Update
August 7 2013
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