Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients

• Conditions: Anemia

• Registration Number: NCT01917851
• Lead Sponsor: OrSense, Ltd.

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 comparing two consecutive Hb values obtained by the NBM system to venous values.

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 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 Timeline

• Study Start: 2011-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-28
• Primary Completion: 2013-08
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-07
• Last Update Posted: 2013-08-07
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Female volunteers aged 18 years and over.
• Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.	1 day