Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608149
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2020-10-21
Brief Title:
Prospective Multi-center Single-arm Observational Study US FDA 522 Pediatric Post Market Surveillance Study
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
CarpediemTM Post Market Surveillance Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 teams 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
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
Detailed Description:
The post market surveillance study is designed to capture data in the real-world clinical setting on the use of the Carpediem system and will evaluate the safety and performance in children requiring CRRT in the US Data on survival and the effectiveness of the Carpediem system on renal function recovery will be evaluated A comprehensive evaluation of subjects being treated with Carpediem will include but is not limited to acuity at hospitalICU admission and prior to CRRT initiation Carpediem treatment parameters laboratory data and requirement for mechanical ventilation andor inotropic support Subject status and requirement for renal replacement therapy post hospital discharge will be evaluated at 30- and 90-days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
True
Is a US Export?:
False
Is an FDA AA801 Violation?:
None