Status:
COMPLETED
Prometra's Utilization in Mitigating Pain (PUMP)
Lead Sponsor:
Flowonix Medical
Conditions:
Intractable Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal dail...
Eligibility Criteria
Inclusion
- suffering from chronic pain
- 18 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00817596
Start Date
January 1 2007
End Date
March 1 2011
Last Update
August 17 2012
Active Locations (3)
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1
Pain Control Network
Louisville, Kentucky, United States, 40205
2
Center for Pain Management
St Louis, Missouri, United States, 63109
3
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103