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ACTIVE NOT RECRUITING
NCT04608149

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

Sponsor: Mozarc Medical US LLC

View on ClinicalTrials.gov

Summary

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 from all subjects treated with the Carpediem™ system will be included in the study. A minimum of 35 subjects will be enrolled and sites may be asked to screen and enroll patients for the study for up to 36 months. Status of subjects discharged from hospital will be collected at 30- and-90 days following hospital discharge by phone interviews in accordance to local standard of care practices, review of in-hospital records or in-clinic visit, as available.

Official title: Carpediem(TM) Post Market Surveillance Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

36

Start Date

2021-01-20

Completion Date

2026-04

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DEVICE

Carpediem System

Continuous renal replacement therapy

Locations (6)

University of Iowa Healthcare

Iowa City, Iowa, United States

Mayo Clinic

Rochester, Minnesota, United States

Golisano Children's Hospital

Rochester, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's

Seattle, Washington, United States