Prometra's Utilization in Mitigating Pain (PUMP)
PUMP
1 other identifier
interventional
110
1 country
3
Brief Summary
Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
July 31, 2012
CompletedAugust 17, 2012
August 1, 2012
1.2 years
January 5, 2009
March 2, 2012
August 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.
Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient. The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio.
6 months - acute study
Interventions
Implantation of pump/catheter for infusion of morphine into the intrathecal space
Eligibility Criteria
You may qualify if:
- suffering from chronic pain
- years of age or older
- life expectancy \>6 months
- failure to respond to less invasive methods
- patient undergone successful morphine trial
- patient agrees with Protocol requirements
- patient considered good subject per clinician
You may not qualify if:
- Existing spinal problems that prevent treatment
- systemic infection
- patient is pregnant or breast feeding
- known allergy or sensitivity to materials
- coexisting medical condition that precludes pump usage
- subject requires MRI post procedure
- subject unwilling/unable to comply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flowonix Medicallead
Study Sites (3)
Pain Control Network
Louisville, Kentucky, 40205, United States
Center for Pain Management
St Louis, Missouri, 63109, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Manager
- Organization
- Medasys, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
January 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2011
Last Updated
August 17, 2012
Results First Posted
July 31, 2012
Record last verified: 2012-08