Prometra Post-Approval Study

Completed · Not applicable

Conditions studied: Chronic Pain, Cancer Pain, Intractable Pain, Back Pain

In brief

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.

Key facts

Study ID

NCT01854229

Run by

Flowonix Medical

People needed

400

Starts

2013-06-20

Expected to finish

2023-03-15

Last updated by the study team

2023-10-18

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Perlman Clinic — La Jolla, California, United States
• Pacific Pain Physicians — Santa Barbara, California, United States
• Evolve Restorative Center — Santa Barbara, California, United States
• Summit Pain Alliance — Santa Rosa, California, United States
• BioHealth Pain Management — Torrance, California, United States
• Interventional Pain Management — Daytona Beach, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Palm Beach Pain Management — Lake Worth, Florida, United States
• Pain Institute of Tampa — Tampa, Florida, United States
• Global Scientific Innovations — Evansville, Indiana, United States
• Summit Pain Management — Fort Wayne, Indiana, United States
• Summit Research Institute — Fort Wayne, Indiana, United States
• Interventional Pain Management Specialists — Overland Park, Kansas, United States
• Bluegrass Pain Consultants — Louisville, Kentucky, United States
• Kentuckiana Pain Specialists — Louisville, Kentucky, United States
• Neuroscience and Pain Institute — Covington, Louisiana, United States
• Integrated Pain and Neuroscience — New Orleans, Louisiana, United States
• Jackson Anesthesia Pain Center — Jackson, Mississippi, United States
• Triumph Medical — Asheville, North Carolina, United States
• Integrated Pain Solutions — Columbus, Ohio, United States
• Pain Management Institute — Wooster, Ohio, United States
• Neurospine Institute — Eugene, Oregon, United States
• Pain Care of Oregon — Medford, Oregon, United States
• Fox Chase Pain Management Associates — Trevose, Pennsylvania, United States
• Space City Pain Specialists — Webster, Texas, United States

Full record on ClinicalTrials.gov

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