NBM-200 Clinical Study in Blood Donation Setting

NCT05217576 | Completed FDA Device

• 1 other identifier: OrSense-001
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemoglobin H

Outcome Measures

Primary Outcomes (1)

• Bias

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

  24 hours

Study Arms (2)

Comparison

OTHER

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

Precision A & B

OTHER

Precision study: 1. 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). 2. 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

Interventions

NBM-200 DEVICE

Finger Prick and Venipuncture

Also known as: HemoCue-301-Hb

Comparison; Precision A & B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular donors and volunteers

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• OneBlood, Inc.: lead
• OrSense, Ltd.: collaborator

Study Sites (3)

Palm Harbor Donor Center

Palm Harbor, Florida, 34684, United States

Location

OneBlood St. Pete Main Donor Center

St. Petersburg, Florida, 33716, United States

Location

Tampa- Dale Mabry OneBlood Donor Center

Tampa, Florida, 33624, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: February 1, 2022
• Study Start: September 21, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)