Prometra's Utilization in Mitigating Pain (PUMP)

Not Applicable

Completed

• Conditions: Intractable Pain

• Registration Number: NCT00817596
• Lead Sponsor: Flowonix Medical

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 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-03
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Study Completion: 2011-03
• Results First Submitted: 2012-03-02
• Results First Submitted QC: 2012-06-25
• Results First Posted: 2012-07-31
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.	6 months - acute study	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.

Trial Locations

Locations (3)

Pain Control Network; 🇺🇸 Louisville, Kentucky, United States

Center for Pain Management; 🇺🇸 St. Louis,, Missouri, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States