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Completed

NCT Number: NCT05217576

NBM-200 Clinical Study in Blood Donation Setting

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.

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Key information

Conditions

Hemoglobin H

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palm Harbor Donor Center, Palm Harbor, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regular donors and volunteers

Exclusion criteria

  • Pregnancy

Treatment and study plan

NBM-200

Device

Finger Prick and Venipuncture

Other names: HemoCue-301-Hb

Primary outcomes

  1. Bias

    Time frame: 24 hours

    The mean bias between the NBM-200 and HemoCue readings and the laboratory reference

Sponsors and collaborators

Lead sponsor

OneBlood, Inc.

Other

Collaborators

  • OrSense, Ltd.

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2022
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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