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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia

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 Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: OrSense, Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 28, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Hb; Accurate; noninvasive measurement
• Other Study ID Numbers: NBMHB-PRS-2