A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
This study is proposed under part of the post-Premarket Approval (PMA) requirements. This
study is a prospective, non-randomized, open-label, multicenter study. It will be performed
at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed
for a total of five years.
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
2. Patient is at least 22 years of age.
3. Investigator considers the patient to be able and willing to fulfill all study
4. Patient has provided written informed consent to participate in the study.
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
3. Patient is pregnant or breast-feeding or is of child-bearing potential and not
employing effective birth control.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of granuloma formation
The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.
Outcome Time Frame:
United States: Institutional Review Board
- Chronic Pain
- Cancer Pain
- Intractable Pain
- Back Pain
- Implantable Infusion Pumps
- Intrathecal Pump
- Back Pain
- Pain, Intractable