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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 is a clinical trial that was terminated before completion, run by Nuwellis. The registered enrollment target is 97 participants.
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.
Interventions
- DEVICE Aquadex™ System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2023-09-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04644731
The ClinicalTrials.gov registry entry for NCT04644731 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuwellis, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aquadex™ System is the first listed.
NCT04644731 reports 0 study locations.
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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