NBM-200 Clinical Study in Blood Donation Setting

Not Applicable

Completed

• Conditions: Hemoglobin H

• Registration Number: NCT05217576
• Lead Sponsor: OneBlood, Inc.

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 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.

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 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.

Study Timeline

• Study Start: 2018-09-21
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Study First Submitted: 2021-09-09
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Regular donors and volunteers

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bias	24 hours	The mean bias between the NBM-200 and HemoCue readings and the laboratory reference

Trial Locations

Locations (3)

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, United States