BVA-200 vs BVA-100 Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Kidney Diseases; Diabetes; Thyroid Diseases; Anemia; Trauma; High Blood Pressure; High Cholesterol; Other Disease; Clotting Disorder
• Intervention / Treatment: Diagnostic test: BVA-200

Detailed Description

Measurements of human blood volume will be made via the indicator dilution method, using gamma counter readings of the concentration of I-131 in a subject's blood sample taken after radio-iodinated Human Serum Albumin (HSA) has been injected into the bloodstream via venous access. Each subject receiving an injection will have five separate blood samples taken, which will be analyzed separately. Each of the five measurements will be conducted in duplicate with the BVA-100 instrument and the BVA-200 instrument. Sufficient blood will be withdrawn at each phlebotomy to permit such duplicate measurement.

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. An effort will be made to ensure a range of ages and a balance of the sexes.

Subjects will be enrolled and consented sequentially. The University of Tennessee Medical Center site will document any patient who is not enrolled in the study sequentially and the reason why or who declines enrollment. Demographics of patients not enrolled will be collected to permit identification of any trends in non-enrollment. We do not anticipate any sequential patient not being offered the opportunity to participate in order to assure that there is no bias in selection of patients ("all-comers").

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Oak Ridge, Tennessee, United States, 37830
      • Daxor Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Age: Over18 years;
2. Able and willing to provide informed written consent.
3. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish equivalence of BVA-200 to BVA-100 in TBV, RCV, PV and ATR	Comparison of a sufficient number of full 5-point time-zero blood volume measurements between BVA-100 and BVA-200 devices, to establish substantial equivalence, including measurement of: Total Blood Volume (TBV); Red Cell Volume (RCV); Plasma Volume (PV); Albumin transudation rate (ATR)	Approximately 6 months.
Filling consistency validation	Validation of filling consistency of at least 100 whole blood quantitative collection cartridges, in at least 40 sets of 5 samples from the same patient	Approximately 6 months.
Usability	Validation of the ability of personnel who are not laboratorians to understand the test procedures and perform the measurement after receiving training materials (which may be a combination of written instructions, video instructions, and individual instruction) in the use of the instrument. Usability is evaluated through a User Validation Survey consisting of yes or no questions, as well as questions answered on a scale of 1 (strongly disagree) to 5 (strongly agree), where 5 is the most favorable outcome.	Approximately 6 months.

Collaborators and Investigators

• Sponsor: Daxor Corporation
• Collaborators: Oregon Health and Science University; Stern Cardiovascular Foundation, Inc.
• Investigators: Principal Investigator: Jonathan Feldschuh, Daxor Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Diagnostic; Blood volume; Point of care; Fluid management
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Hematologic Diseases; Hemorrhagic Disorders; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Kidney Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Disease; Thyroid Diseases; Hypercholesterolemia
• Other Study ID Numbers: BVA-200 Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made available to other researchers.

Drug and device information, study documents

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