Clinical trial · Interventional
Prometra Post-Approval Study
A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
NCT01854229CI-TRIAL-00070571completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Back Pain | — | UNRESOLVED | — |
| Cancer Pain | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Intractable Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prometra Programmable Intrathecal Infusion Pump | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prospective pump candidates
- description
- New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
- interventionNames
- Device: Prometra Programmable Intrathecal Infusion Pump
- type
- ACTIVE_COMPARATOR
- label
- Previous IDE study subjects continuing with the therapy
- description
- 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.
- interventionNames
- Device: Prometra Programmable Intrathecal Infusion Pump
Primary outcomes (1)
- measure
- Rate of granuloma formation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDRauck R, Deer T, Rosen S, Padda G, Barsa J, Dunbar E, Dwarakanath G. Long-term follow-up of a novel implantable programmable infusion pump. Neuromodulation. 2013 Mar-Apr;16(2):163-7. doi: 10.1111/j.1525-1403.2012.00515.x. Epub 2012 Oct 11. PMID 23057877