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NBM-200 Clinical Study in Blood Donation Setting

NCT05217576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2022-02-01

No results posted yet for this study

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.

Conditions

  • Hemoglobin H

Interventions

DEVICE

NBM-200

Finger Prick and Venipuncture

Sponsors & Collaborators

  • OrSense, Ltd.

    collaborator INDUSTRY

  • OneBlood, Inc.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2018-11-02
Completion
2018-11-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217576 on ClinicalTrials.gov