|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080012 / PAS001 |
| Date Original Protocol Accepted |
05/03/2012
|
| Date Current Protocol Accepted |
07/12/2022
|
| Study Name |
Prometra Programmable Pump System
|
| Device Name |
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
|
| Clinical Trial Number(s) |
NCT00817596 NCT00866164
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, non-randomized, open-label, multicenter study, which will include subjects from the premarket study cohorts and new enrollment of subjects receiving the device in the postmarket.
|
| Study Population |
Group A: Active prospective study subjects.
Group B: Subjects previously enrolled in the premarket trials PUMP I or PUMP II will be offered voluntary participation in the post-approval study. Subjects in Group B will be followed for a total of five years, which includes all time enrolled in the previous PUMP study.
|
| Sample Size |
400 patients
|
| Key Study Endpoints |
Primary endpoint is to assess long-term occurrence and safety as a result of granuloma formation.
Secondary endpoints are to assess the long-term device performance including:
-Pump failure, including time to occurrence, type, and number of occurrences
-Pump battery life
The additional endpoint will include:
-Device-related adverse events
-Device-related serious adverse events
-The effect of race and ethnicity on granuloma formation
-The effect of alternative drugs on granuloma formation
|
| Follow-up Visits and Length of Follow-up |
5 years
Subjects shall be seen at least once every 90 days (± 30 days) from the date of implantation (Group A) or enrollment (Group B) throughout the study
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
400
|
| Actual Number of Sites Enrolled |
28
|
| Patient Follow-up Rate |
N/A
|
| Final Safety Findings |
The extremely low number of confirmed granuloma formation during the course of this study provides reasonable and continued
assurance of the long-term safety of the Prometra Programmable Infusion System.
|
| Final Effect Findings |
The extremely low number of occurrences of pump failure and low battery life provides reasonable and continued assurance of the longterm
device performance of the Prometra Programmable Infusion System.
|
| Study Strengths & Weaknesses |
The majority of study deviations were due to out-of-window visits (60.10%), with the least deviations (12.86 %) due to patients not
signing the informed consent. However, baseline protocol demographics showed that minority enrollment percentages were
only around 5%, rendering it difficult to truly determine the effects of race on granuloma formation.
|
| Recommendations for Labeling Changes |
There are no recommendations for labeling changes.
|
