Prometra Post-Approval Study
CompletedNot applicableNCT01854229
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
- Conditions
- Chronic Pain
- Cancer Pain
- Intractable Pain
- Back Pain
- Interventions
- Device: Prometra Programmable Intrathecal Infusion Pump
- Sponsor
- Flowonix Medical
- Start date
- 2013-06-20
- Primary completion
- 2023-03-15
- Sex
- All
- Age range
- from 22 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 26
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01854229