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Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.

Completed · NCT04608149

Conditions: Acute Kidney Injury, Fluid Overload

At a glance

Research payments reported, 2025
$10,489
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
36

About the trial

Sponsor
Mozarc Medical US LLC
Tested
Carpediem System (device)
Dates
Started 2021-01-20; completion 2026-04-30
Results posted
Not yet

The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Participating clinicians will manage subjects in accordance to their local standard of care practices and decisions on initiating, modifying or discontinuing CRRT are up to the local investigative team's prescription. A minimum of 10 centers in the United States, that have been trained on the use of the Carpediem™ system, will be invited to participate in the study. After obtaining institutional review board approval and written informed consent from a parent or legally authorized representative (LAR), data f…

From ClinicalTrials.gov, last updated 2026-09-14. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Mozarc Medical US LLC reported $10,489 in research payments for this study in 2025 (2 payments).

Products named: Carpediem

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.