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NCT04644731 · ClinicalTrials.gov registry record
Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
A clinical trial, sponsored by Nuwellis.
- Terminated
- Registry status
- 97
- Enrollment target
NCT04644731: Clinical Trial study, sponsored by Nuwellis.
NCT04644731 is a clinical trial that was terminated before completion, run by Nuwellis. The registered enrollment target is 97 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04644731 was terminated before completion, sponsored by Nuwellis.
- TERMINATED
- Registry status
- 97 participants
- Enrollment target
Study Summary
The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from treatment at the time of registry approval by the IRB) or are scheduled to be treated (i.e., prospective data for on-label treatment after registry approval by the IRB) with Aquadex therapy according to local standard of care practices and decisions. All prospective data will be from on-label Aquadex treatment of pediatric patients weighing 20 kilograms or more. No data from prospective off-label treatment (i.e., Aquadex treatment with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg) will be included in the registry. An estimated 10 sites in the United States who have received training in extracorporeal therapy and the Aquadex™ system will enroll a minimum of 500 patients.
Primary Outcome
Patient survive treatment course
Interventions
- DEVICE Aquadex™ System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2023-09-13 |
Why NCT04644731 stopped before completion
NCT04644731 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 97 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Aquadex™ System is the first listed.
NCT04644731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04644731 about?
NCT04644731 is a clinical study titled "Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)". The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from treatment at the time of registry approval by the IRB) or are scheduled to b...
What is the current status of trial NCT04644731?
This trial is currently terminated. The enrollment target is 97 participants. The study started on 2021-04-09. Estimated completion is 2023-09-13.
What interventions are being tested in trial NCT04644731?
The interventions under investigation include: Aquadex™ System (DEVICE).
Who is sponsoring clinical trial NCT04644731?
This trial is sponsored by Nuwellis, which has 7 total clinical trials registered on ClinicalTrials.gov.
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