|
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.
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Recommendations for Labeling Changes |
There are no recommendations for labeling changes.
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