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NBM-200 Clinical Study in Blood Donation Setting

Sponsor
OneBlood, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT05217576
Collaborator
OrSense, Ltd. (Industry)
387
Enrollment
3
Locations
2
Arms
1.4
Actual Duration (Months)
129
Patients Per Site
93.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NBM-200
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
387 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
NBM-200 Clinical Study in Blood Donation Setting
Actual Study Start Date :
Sep 21, 2018
Actual Primary Completion Date :
Nov 2, 2018
Actual Study Completion Date :
Nov 2, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bias [24 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Regular donors and volunteers
    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palm Harbor Donor Center Palm Harbor Florida United States 34684
    2 OneBlood St. Pete Main Donor Center Saint Petersburg Florida United States 33716
    3 Tampa- Dale Mabry OneBlood Donor Center Tampa Florida United States 33624

    Sponsors and Collaborators

    • OneBlood, Inc.
    • OrSense, Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OneBlood, Inc.
    ClinicalTrials.gov Identifier:
    NCT05217576
    Other Study ID Numbers:
    • OrSense-001
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Feb 1, 2022