Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2013-06-20
2023-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prospective pump candidates
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
22 Years
ALL
No
Sponsors
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Flowonix Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Cory Brantley
Role: STUDY_DIRECTOR
Flowonix Medical
Locations
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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
Countries
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References
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Rauck R, Deer T, Rosen S, Padda G, Barsa J, Dunbar E, Dwarakanath G. Long-term follow-up of a novel implantable programmable infusion pump. Neuromodulation. 2013 Mar-Apr;16(2):163-7. doi: 10.1111/j.1525-1403.2012.00515.x. Epub 2012 Oct 11.
Related Links
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American Academy of Pain Medicine
North American Neuromodulation Society
American Society of Regional Anesthesia and Pain Medicine
World Institute of Pain
Other Identifiers
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PAS-01
Identifier Type: -
Identifier Source: org_study_id
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