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|
| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS200006 / PSS001 |
| Date Original Plan Accepted |
10/01/2020
|
| Date Current Plan Accepted |
04/25/2024
|
| Study Name |
CARPEDIEM 522
|
| Device Name |
Carpediem
|
| Root Document Number |
DEN180055
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, single-arm, observational study to capture data on children who undergo CRRT using the Carpediem™ system. This is a new enrollment study.
Data from subjects who were treated with the Carpediem™ system prior to Study Site Activation will also be included in the Post Market Surveillance Study if study entrance criteria are met.
|
| Study Population |
All patients who receive CRRT with the Carpediem™ system, as prescribed by the investigator, will be offered participation in the post market surveillance study after obtaining parental consent. There is no comparison group in this study.
|
| Sample Size |
The study will enroll at least 30 subjects treated with the Carpediem™ system. 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.
Study Milestones:
- First patient enrolled by July 2021
- 20% of patients enrolled by October 2021
- 50% of patients enrolled by January 2022
- 100% of patients enrolled by April 2023
- Final report submission by August 2023
|
| Key Study Endpoints |
The primary endpoints are:
1. Percent of patient survival to CRRT discontinuation
2. Percent of patient survival to intensive care unit (ICU) discharge
The secondary endpoints are:
1. Survival at hospital discharge, and 30 and 90 days
2. Hospital and ICU length of stay
3. Quantification of CARPEDIEM system-related adverse events
4. Renal function recovery at hospital discharge and 30 and 90 days
5. Characterization of survival based on variables including, but not limited to; demographic data, laboratory values, patient acuity prior to CRRT initiation and CRRT treatment parameters
6. Time to CRRT discontinuation
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| Follow-up Visits and Length of Follow-up |
Data from each patient treated with CARPEDIEM will be collected throughout their hospitalization and at 30- and 90-days following hospital discharge. Daily patient assessments and device performance data will be collected in addition to vital status reviews at 30 and 90 days after hospital discharge. Total length of follow-up: 90 days
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Two new non-device related adverse events were reported.
Effectiveness Results
Two device deficiencies were reported.
No protocol deviations were reported.
|
| Actual Number of Patients Enrolled |
11
|
| Actual Number of Sites Enrolled |
6
|
| Patient Followup Rate |
During this reporting period: Completed: 4 (36.4%), Not completed: 7 (63.6%), Lost to follow-up: 0 (0%), Exit the study: 5 (100%)
|
| Study Strengths and Weaknesses |
Weaknesses: Slow study enrollment, small sample size, no comparator group.
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