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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01917851
• Other study ID #: NBMHB-PRS-2
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2013
• Last updated: August 6, 2013
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: OrSense, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OrSense, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.		1 day	No