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.

Study Overview

• Status: Completed
• Conditions: Hemoglobin H
• Intervention / Treatment: Device: NBM-200

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 Type: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Palm Harbor, Florida, United States, 34684
      • Palm Harbor Donor Center
    • Saint Petersburg, Florida, United States, 33716
      • OneBlood St. Pete Main Donor Center
    • Tampa, Florida, United States, 33624
      • Tampa- Dale Mabry OneBlood Donor Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Regular donors and volunteers

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Comparison; Comparison study: The participants (at least 300) will be tested once with each of the 3 devices. First, a measurement with the NBM-200 will be performed according to the user manual. The best finger to use, in order of preference: 1) right thumb 2) left thumb 3) right index 4) left index. The POC capillary test will follow the NBM-200 test, and the venous test will be performed last. A venous blood sample will be obtained from all participants in the comparison study, even if a subject is designated to donate and is deferred from donation because of low hemoglobin.	Device: NBM-200; Finger Prick and Venipuncture; Other Names: HemoCue-301-Hb
Other: Precision A & B; Precision study: At least 12 subjects will be tested 6 consecutive times with the NBM-200, on either the right or left thumb, and then 6 times with the capillary device (with a separate finger-prick for each test).; At least 3 males and 3 females at 2 study sites (total of 12), preferably with hemoglobin levels close to the cutoff levels of 12.5 g/dL for females and 13 g/dL for males. Each subject will be tested on each of their right and left thumbs and indices (4 fingers) using at least two operators and two NBM-200 instruments on each finger. A laboratory test with venous blood is not required for participants in the precision study.	Device: NBM-200; Finger Prick and Venipuncture; Other Names: HemoCue-301-Hb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bias	The mean bias between the NBM-200 and HemoCue readings and the laboratory reference	24 hours

Collaborators and Investigators

• Sponsor: OneBlood, Inc.
• Collaborators: OrSense, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): November 2, 2018
• Study Completion (Actual): November 2, 2018

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: OrSense-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the conclusion of the study, the data will be published in reputable clinical journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No