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

O

OrSense

Status

Unknown

Conditions

Anemia

Study type

Observational

Funder types

Industry

Identifiers

NCT01915953
QD04.5.1-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

anemia
Description:
Measuring Hb valuse on anemia patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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