Status:

UNKNOWN

A Trial to Evaluate the Precision and Accuracy of the NBM-200 Series When Used in a Continuous Prospective Mode

Lead Sponsor:

OrSense, Ltd.

Conditions:

Anemia

Eligibility:

All Genders

18-95 years

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 comp...

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 i...

Eligibility Criteria

Inclusion

  • Aged 18 years and over
  • Healthy volunteers
  • Anemia patients

Exclusion

  • Participants under the age of 18 years
  • Patients with significant deformity, degenerative changes or oedema of the thumb or index fingers
  • Patients with localized infection, ulceration or skin breaks involving the fingers
  • Patients with vascular disease or Raynaud's phenomenon affecting the fingers
  • Participants who are unable to give informed written consent
  • Pregnancy

Key Trial Info

Start Date :

November 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2013

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT01917487

Start Date

November 1 2011

End Date

November 1 2013

Last Update

September 10 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, Israel, Israel, 52621