Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients
1 other identifier
observational
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 7, 2013
July 1, 2013
2.3 years
July 28, 2013
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.
1 day
Eligibility Criteria
Pregnant women
You may qualify if:
- Female volunteers aged 18 years and over.
- Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrSense, Ltd.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eran Hadar, MD
Rabin Medical Center
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2013
First Posted
August 7, 2013
Study Start
April 1, 2011
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
August 7, 2013
Record last verified: 2013-07