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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01917487

Enrollment

150

Registered

2013-08-06

Start date

2011-11-30

Completion date

2013-11-30

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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 comparing two consecutive Hb values obtained by the NBM system to venous values.

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. Addendum: Reproducibility Procedure (optional) Each subject will be measured by each one of the three operators, three NBM system units, 3 times consecutively (without removal) on his right thumb and right index finger. The order of each measurement sequence will be randomized (thumb/index). There will be an intermission of 3 to 5 minutes between the 3 measurement sets taken on each participant. In case of a longer intermission, the subject will be measured again and the previous results will be excluded.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Compare the Hb values from the Noninvasive Blood Monitor(NBM200) series against the Hb from the lab blood analyser on healthy volunteers and oncology patients	1 day

Countries

Israel

Outcome results