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Status unknownNCT01917851Updated Aug 7, 2013

Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients

An observational study in Anemia, sponsored by OrSense, Ltd.. Status unknown. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by OrSense, Ltd. · Observational

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

Read the 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 CBC or Hb blood analyzers.

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Conditions studied

  • Anemia

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Keywords

  • Accurate
  • Hb
  • noninvasive measurement
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In context

Anemia

1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.

This study's enrollment of 300 is above the median of 200 across 331 observational studies indexed under Anemia.

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Lead sponsor

OrSense, Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female volunteers aged 18 years and over.
  • Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.

Exclusion criteria

Exclusion Criteria:

  • Participants under the age of 18 years
  • Significant deformity, degenerative changes or edema of the thumb or index fingers
  • Localized infection, ulceration or skin breaks involving the fingers
  • Low peripheral body temperature (tissue perfusion) \<36.0˚C
  • Vascular disease or Raynaud's phenomenon affecting the fingers
  • Participants who are unable to give informed written consent
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Study design

Time perspective
Prospective
Enrollment
300 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.

    Time frame: 1 day

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Aug 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2013
First posted
Aug 7, 2013
Start
Apr 2011
Primary completionEst.
Aug 2013
CompletionEst.
Dec 2013
Last update
Aug 7, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01917851
Lead sponsor
OrSense, Ltd.
Responsible party
Sponsor
First posted
Aug 7, 2013
Start date
Apr 2011
Primary completion
Aug 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Aug 7, 2013

Study contacts

Eran Hadar, MD
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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