A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Flowonix Medical
- Enrollment
- 400
- Locations
- 26
- Primary Endpoint
- Rate of granuloma formation
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Patient is at least 22 years of age.
- •Investigator considers the patient to be able and willing to fulfill all study requirements.
- •Patient has provided written informed consent to participate in the study.
Exclusion Criteria
- •Patient meets any of the contraindications for use of the Prometra System
- •Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
- •Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
Arms & Interventions
Prospective pump candidates
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Intervention: Prometra Programmable Intrathecal Infusion Pump (Device)
Previous IDE study subjects continuing with the therapy
Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.
Intervention: Prometra Programmable Intrathecal Infusion Pump (Device)
Outcomes
Primary Outcomes
Rate of granuloma formation
Time Frame: Five years
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.
Secondary Outcomes
- Pump failure(Five years)
- Pump battery life(Five years)