Spots Global Cancer Trial Database for Prometra Post-Approval Study
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We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Prometra Post-Approval Study
Official Title: A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Study ID: NCT01854229
Interventions
Study Description
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.
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Nexus Pain Care, Provo, Utah, United States
Contact Details
Name: Cory Brantley
Affiliation: Flowonix Medical
Role: STUDY_DIRECTOR
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