Prometra's Utilization in Mitigating Pain (PUMP)

Intractable Pain Clinical Trial

— PUMP  

Official title:

Prometra's Utilization in Mitigating Pain (PUMP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817596
• Other study ID #: G060192
• Status: Completed
• Phase: N/A
• First received: January 5, 2009
• Last updated: August 13, 2012
• Start date: January 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Flowonix Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2011
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intractable Pain
• Pain, Intractable

Intervention

Device:
• Infusion Pump (Prometra)
Implantation of pump/catheter for infusion of morphine into the intrathecal space

Locations

Country	Name	City	State
United States	Pain Control Network	Louisville	Kentucky
United States	Center for Pain Management	St. Louis,	Missouri
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Flowonix Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes