BVA-200 vs BVA-100 Validation Study

NCT06227819 | Completed FDA Device

• 1 other identifier: BVA-200 Validation
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; High Blood Pressure; High Cholesterol; Anemia; Diabetes; Thyroid Diseases; Kidney Diseases; Clotting Disorder; Trauma; Other Disease

Keywords

Blood volume; Point of care; Fluid management; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Establish equivalence of BVA-200 to BVA-100

  Comparison of a sufficient number of indicator-dilution volume measurements between BVA-100 and BVA-200 devices to establish substantial equivalence.

  Approximately 6 months.

Secondary Outcomes (3)

• Establish equivalence of BVA-200 to BVA-100 in TBV, RCV, PV and ATR

  Approximately 6 months.

• Filling consistency validation

  Approximately 6 months.

• Usability

  Approximately 6 months.

Interventions

BVA-200 DIAGNOSTIC_TEST

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.

Eligibility Criteria

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

Study Population

The proposed study will be open to any volunteer meeting the inclusion/exclusion criteria listed below. We intend to highlight differential analysis of clinical patients from exemplary disease states (such as congestive heart failure and chronic kidney disease), as well as other population characteristics such as age, sex, race, etc.

You may qualify if:

• Age: Over18 years;
• Able and willing to provide informed written consent.
• Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study.

You may not qualify if:

• Pregnant women or nursing mothers.
• Women of childbearing potential not using adequate birth control methods.
• Known hypersensitivity to iodine or eggs.
• Other clinical basis for precluding the use of radioactive materials.
• Has previously been enrolled in, and completed, the study.

Sponsors & Collaborators

• Daxor Corporation: lead
• Stern Cardiovascular Foundation, Inc.: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Daxor Corporation

Oak Ridge, Tennessee, 37830, United States

Location

MeSH Terms

Conditions

Heart Failure; Hypertension; Hypercholesterolemia; Anemia; Diabetes Mellitus; Thyroid Diseases; Kidney Diseases; Hemostatic Disorders; Wounds and Injuries; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhagic Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Feldschuh

  Daxor Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 29, 2024
• Study Start: May 23, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)