About this trial
Last updated 2 years ago
Study ID
PAS-01
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
22+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
The Prometra Pump is approved by the FDA for use in the United States. The purpose of
this study is to collect long-term safety data on the Prometra Pump.
What are the participation requirements?
Inclusion Criteria
1. Patient meets at least one of the following:
- is suffering from malignant pain (i.e., cancer pain)
- has chronic, non-malignant pain
- subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
- Patient with an existing implantable pump for pain therapy that requires replacement
2. Patient is at least 22 years of age.
3. Investigator considers the patient to be able and willing to fulfill all study requirements.
4. Patient has provided written informed consent to participate in the study.
Exclusion Criteria
1. Patient meets any of the contraindications for use of the Prometra System
2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.