Status:
COMPLETED
NBM-200 Clinical Study in Blood Donation Setting
Lead Sponsor:
OneBlood, Inc.
Collaborating Sponsors:
OrSense, Ltd.
Conditions:
Hemoglobin H
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rat...
Detailed Description
The proposed study plan will support a 510(k) submission for the non-invasive NBM-200 system with a blood bank indication. In accordance with the agency's suggestion, OrSense plans to use as a predica...
Eligibility Criteria
Inclusion
- Regular donors and volunteers
Exclusion
- Pregnancy
Key Trial Info
Start Date :
September 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT05217576
Start Date
September 21 2018
End Date
November 2 2018
Last Update
February 1 2022
Active Locations (3)
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1
Palm Harbor Donor Center
Palm Harbor, Florida, United States, 34684
2
OneBlood St. Pete Main Donor Center
St. Petersburg, Florida, United States, 33716
3
Tampa- Dale Mabry OneBlood Donor Center
Tampa, Florida, United States, 33624