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BVA-200 vs BVA-100 Validation Study

NCT06227819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2024-01-29

No results posted yet for this study

Summary

The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.

Conditions

Interventions

DIAGNOSTIC_TEST

BVA-200

Blood samples collected for measurement with the BVA-100 will also be tested with the BVA-200. The BVA-200 uses whole blood collection cartridges which allow for a precise amount of blood to be measured without the need to first centrifuge and then pipette plasma aliquots. A small amount of whole blood from each sample will be set aside for BVA-200 use, while the remainder of the blood sample is used for BVA-100 measurement. The BVA-200 device was developed with the support of the Department of Defense through Phase I (W81XWH19C0048) and Phase II (W81XWH20C0025) SBIR contracts.

Sponsors & Collaborators

  • Stern Cardiovascular Foundation, Inc.

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • Daxor Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan Feldschuh · Daxor Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06227819 on ClinicalTrials.gov