A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Status: Completed
Location: See all (26) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Perlman Clinic
La Jolla
Evolve Restorative Center
Santa Barbara
Pacific Pain Physicians
Santa Barbara
Summit Pain Alliance
Santa Rosa
BioHealth Pain Management
Torrance
Florida
Interventional Pain Management
Daytona Beach
Florida Institute of Medical Research
Jacksonville
Palm Beach Pain Management
Lake Worth
Pain Institute of Tampa
Tampa
Indiana
Global Scientific Innovations
Evansville
Summit Pain Management
Fort Wayne
Summit Research Institute
Fort Wayne
Kansas
Interventional Pain Management Specialists
Overland Park
Kentucky
Bluegrass Pain Consultants
Louisville
Kentuckiana Pain Specialists
Louisville
Louisiana
Neuroscience and Pain Institute
Covington
Integrated Pain and Neuroscience
New Orleans
Mississippi
Jackson Anesthesia Pain Center
Jackson
North Carolina
Triumph Medical
Asheville
Ohio
Integrated Pain Solutions
Columbus
Pain Management Institute
Wooster
Oregon
Neurospine Institute
Eugene
Pain Care of Oregon
Medford
Pennsylvania
Fox Chase Pain Management Associates
Trevose
Texas
Space City Pain Specialists
Webster
Utah
Nexus Pain Care
Provo
Time Frame
Start Date: 2013-06-20
Completion Date: 2023-03-15
Participants
Target number of participants: 400
Treatments
Active_comparator: Prospective pump candidates
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Active_comparator: 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.
Authors
John Barsa, George Johnston, Rostam Khoshsar, Todd Bromberg, John Hau, Daniel Roth, Daniel Kloster, Orlando G Florete, Vinod Malik, Eric Royster, Richard Rosenthal, Joseph Savino, Andrew Trobridge, Christopher Nelson, Ajith Nair, Jason Pope, Gregory Phillips, Chad M Domangue, Carroll M McLeod, Javid Baksh, Steven Rosen, Michael Cozzi, Ralph D Mozingo, Anthony Rogers
Related Therapeutic Areas
Sponsors
Leads: Flowonix Medical