Prometra's Utilization in Mitigating Pain (PUMP)

Completed · Not applicable

Conditions studied: Intractable Pain

In brief

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.

Key facts

Study ID

NCT00817596

Run by

Flowonix Medical

People needed

110

Starts

2007-01-01

Expected to finish

2011-03-01

Last updated by the study team

2012-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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