NBM-200 Clinical Study in Blood Donation Setting

Hemoglobin H Clinical Trial

Official title:

NBM-200 Clinical Study in Blood Donation Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217576
• Other study ID #: OrSense-001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: January 2022
• Source: OneBlood, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 rate.

The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result.

The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.

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 predicate an FDA-cleared blood analyzer with a hemoglobin test method that is traceable to the cyanmethemoglobin method or that was standardized and calibrated using the International Council for Standardization in Hematology (ICSH) hemoglobin standard, e.g., the HemoCue-301 or EKF's Hemo Control Hemoglobin Measurement System. OrSense further plans to use the cleared NBM-200 (K142209) as a reference device. Clinical data will be collected in a blood donor population using 3 methods to check hemoglobin (Hb): (1) the non-invasive NBM-200 system; (2) a point-of-care device based on finger sticks that is FDA-cleared for use in blood banks, such as the HemoCue or EKF device; and (3) a laboratory analyzer based on venous blood samples.

Participants will be recruited via email and during their visit to the designated donor rooms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Regular donors and volunteers

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Hemoglobin H

Intervention

Device:
• NBM-200
Finger Prick and Venipuncture

Locations

Country	Name	City	State
United States	Palm Harbor Donor Center	Palm Harbor	Florida
United States	OneBlood St. Pete Main Donor Center	Saint Petersburg	Florida
United States	Tampa- Dale Mabry OneBlood Donor Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
OneBlood, Inc.	OrSense, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias	The mean bias between the NBM-200 and HemoCue readings and the laboratory reference	24 hours