NCT06227819Completed
BVA-200 vs BVA-100 Validation Study
Source: ClinicalTrials.gov · Last updated 29 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 29 Dec 2023
- Start date
- 23 May 2023
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Daxor Corporation
- NCT number
- NCT06227819
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 23 May 2023 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously been enrolled in, and completed, the study.
Other illness
- Known hypersensitivity to iodine or eggs.
Other
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods.
- Other clinical basis for precluding the use of radioactive materials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daxor Corporation Coordinator of this site? Confirm its status | Oak Ridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.