Prometra Post-Approval Study
A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
1 other identifier
interventional
400
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jun 2013
Longer than P75 for not_applicable chronic-pain
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedOctober 18, 2023
October 1, 2023
9.7 years
May 13, 2013
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of granuloma formation
The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.
Five years
Secondary Outcomes (2)
Pump failure
Five years
Pump battery life
Five years
Other Outcomes (4)
Device-related adverse events
Five years
Device-related serious adverse events
Five years
Rate of granuloma formation by race and ethnicity
Five years
- +1 more other outcomes
Study Arms (2)
Prospective pump candidates
ACTIVE COMPARATORNew candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Previous IDE study subjects continuing with the therapy
ACTIVE COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flowonix Medicallead
Study Sites (26)
Perlman Clinic
La Jolla, California, 92037, United States
Pacific Pain Physicians
Santa Barbara, California, 93105, United States
Evolve Restorative Center
Santa Barbara, California, 95403, United States
Summit Pain Alliance
Santa Rosa, California, 95401, United States
BioHealth Pain Management
Torrance, California, 90260, United States
Interventional Pain Management
Daytona Beach, Florida, 32174, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Palm Beach Pain Management
Lake Worth, Florida, 33462, United States
Pain Institute of Tampa
Tampa, Florida, 33603, United States
Global Scientific Innovations
Evansville, Indiana, 47714, United States
Summit Pain Management
Fort Wayne, Indiana, 46802, United States
Summit Research Institute
Fort Wayne, Indiana, 46825, United States
Interventional Pain Management Specialists
Overland Park, Kansas, 66209, United States
Bluegrass Pain Consultants
Louisville, Kentucky, 40202, United States
Kentuckiana Pain Specialists
Louisville, Kentucky, 40241, United States
Neuroscience and Pain Institute
Covington, Louisiana, 70433, United States
Integrated Pain and Neuroscience
New Orleans, Louisiana, 70115, United States
Jackson Anesthesia Pain Center
Jackson, Mississippi, 39202, United States
Triumph Medical
Asheville, North Carolina, 28803, United States
Integrated Pain Solutions
Columbus, Ohio, 43219-1531, United States
Pain Management Institute
Wooster, Ohio, 44691, United States
Neurospine Institute
Eugene, Oregon, 97401, United States
Pain Care of Oregon
Medford, Oregon, 97504, United States
Fox Chase Pain Management Associates
Trevose, Pennsylvania, 19053, United States
Space City Pain Specialists
Webster, Texas, 77598, United States
Nexus Pain Care
Provo, Utah, 84604, United States
Related Publications (1)
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.
PMID: 23057877BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cory Brantley
Flowonix Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 15, 2013
Study Start
June 20, 2013
Primary Completion
March 15, 2023
Study Completion
March 15, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10