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NCT04241718 · ClinicalTrials.gov registry record · NA

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

A NA study, sponsored by Nuwellis.

Terminated
Registry status
NA
Development phase
6
Enrollment target

NCT04241718: Clinical Trial NA study, sponsored by Nuwellis.

NCT04241718 is a NA study that was terminated before completion, run by Nuwellis. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04241718, a NA study, was terminated before completion, sponsored by Nuwellis.

TERMINATED
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Primary Outcome

BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration.

Interventions

  • DEVICE Aquadex FlexFlow System and BVA-100

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-12-19
Est. Completion 2022-12-27
Phase NA
Nuwellis

7 total trials

Why NCT04241718 stopped before completion

NCT04241718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Aquadex FlexFlow System and BVA-100 is the first listed.

NCT04241718 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04241718 about?

NCT04241718 is a clinical study titled "A Feasibility Study on Ultrafiltration and Blood Volume Measurements". The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential mea...

What is the current status of trial NCT04241718?

This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2019-12-19. Estimated completion is 2022-12-27.

What interventions are being tested in trial NCT04241718?

The interventions under investigation include: Aquadex FlexFlow System and BVA-100 (DEVICE).

Who is sponsoring clinical trial NCT04241718?

This trial is sponsored by Nuwellis, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04241718's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04241718, the US trial registry maintained by the National Library of Medicine. NCT04241718 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.