CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
VFI using the FAST PV Technologydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04733664
NCT04733664N/ACompleted
CompareCT.gov

A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients With Extremely Reduced or No Kidney Function

FAST BioMedical·interventional·Posted Feb 2, 2021·Updated Feb 8, 2023

In Brief

A clinical study evaluating VFI using the FAST PV Technology for End Stage Renal Disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The FAST Plasma Volume (PV) Technology will aid in determining the plasma and interstitial volumes of end stage renal disease patients before and after dialysis therapy, providing a more precise understanding of pre and post dialysis volumes and extent of volume removal during the course of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 2, 2021
Enrollment StartOct 29, 2020
Primary CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.4 years ago

Interventions

VFI using the FAST PV Technologydevice

The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.