|
|
| 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 Cohort 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.
|
| 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.
|
| 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
|
| 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.
|
| 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.
|
