Prometra's Utilization in Mitigating Pain (PUMP)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prometra's Utilization in Mitigating Pain (PUMP)|
- Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. [ Time Frame: 6 months - acute study ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||January 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Device: Infusion Pump (Prometra)
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 daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition.
In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.
|United States, Kentucky|
|Pain Control Network|
|Louisville, Kentucky, United States, 40205|
|United States, Missouri|
|Center for Pain Management|
|St. Louis,, Missouri, United States, 63109|
|United States, North Carolina|
|Forsyth Medical Center|
|Winston-Salem, North Carolina, United States, 27103|