A Trial to Evaluate the Precision and Accuracy of the NBM-200 Series When Used in a Continuous Prospective Mode
1 other identifier
observational
150
1 country
1
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 P50-P75 for all trials
Started Nov 2011
1 active site
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
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedSeptember 10, 2013
September 1, 2013
1.9 years
August 1, 2013
September 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
healthy volunteers and oncology patients
You may qualify if:
- Aged 18 years and over
- Healthy volunteers
- Anemia patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrSense, Ltd.lead
Study Sites (1)
The Chaim Sheba Medical Center at Tel Hashomer
Ramat Gan, Israel, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ohad Cohen, Prof.
The Chaim Sheba Medical Center at Tel Hashomer
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2013
First Posted
August 6, 2013
Study Start
November 1, 2011
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
September 10, 2013
Record last verified: 2013-09