Prometra Post-Approval Study

NACompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

June 20, 2013

Primary Completion Date

March 15, 2023

Study Completion Date

March 15, 2023

Conditions
Chronic PainCancer PainIntractable PainBack Pain
Interventions
DEVICE

Prometra Programmable Intrathecal Infusion Pump

There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.

Trial Locations (26)

19053

Fox Chase Pain Management Associates, Trevose

28803

Triumph Medical, Asheville

32174

Interventional Pain Management, Daytona Beach

32257

Florida Institute of Medical Research, Jacksonville

33462

Palm Beach Pain Management, Lake Worth

33603

Pain Institute of Tampa, Tampa

39202

Jackson Anesthesia Pain Center, Jackson

40202

Bluegrass Pain Consultants, Louisville

40241

Kentuckiana Pain Specialists, Louisville

44691

Pain Management Institute, Wooster

46802

Summit Pain Management, Fort Wayne

46825

Summit Research Institute, Fort Wayne

47714

Global Scientific Innovations, Evansville

66209

Interventional Pain Management Specialists, Overland Park

70115

Integrated Pain and Neuroscience, New Orleans

70433

Neuroscience and Pain Institute, Covington

77598

Space City Pain Specialists, Webster

84604

Nexus Pain Care, Provo

90260

BioHealth Pain Management, Torrance

92037

Perlman Clinic, La Jolla

93105

Pacific Pain Physicians, Santa Barbara

95401

Summit Pain Alliance, Santa Rosa

95403

Evolve Restorative Center, Santa Barbara

97401

Neurospine Institute, Eugene

97504

Pain Care of Oregon, Medford

43219-1531

Integrated Pain Solutions, Columbus

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Flowonix Medical

INDUSTRY

NCT01854229 - Prometra Post-Approval Study | Biotech Hunter | Biotech Hunter