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

August 4, 2013 updated by: OrSense, Ltd.
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

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 complete blood count or Hb blood analyzers.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Yaacov, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hematology pateints

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
anemia
Measuring Hb valuse on anemia patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compre the Hb values from the NBM200 series gainst the Hb from the lab blood analyser on Hematology pateints
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrSense, Ltd.

Investigators

  • Principal Investigator: Abraham Korenberg, MD, Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QD04.5.1-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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