CompletedNot Applicable

BVA-200 vs BVA-100 Validation Study

United States62 participantsStarted 2023-05-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Establish equivalence of BVA-200 to BVA-100

Timeframe: Approximately 6 months.

Trial details

NCT IDNCT06227819

SponsorDaxor Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Heart Failure trials