A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP

Anemia Clinical Trial

Official title:

A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01915953
• Other study ID #: QD04.5.1-15
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2013
• Last updated: August 4, 2013
• Start date: February 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

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 complete blood count or Hb blood analyzers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Participants aged 18 years and over

Exclusion Criteria:

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Beer Yaacov

Sponsors (1)

Lead Sponsor	Collaborator
OrSense, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compre the Hb values from the NBM200 series gainst the Hb from the lab blood analyser on Hematology pateints		1 day	No