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Completed

NCT Number: NCT00817596

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Control Network, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion Pump (Prometra)

Device

Implantation of pump/catheter for infusion of morphine into the intrathecal space

Other names: Prometra

Primary outcomes

  1. Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Flowonix Medical

Industry

Registry information

Acronym: PUMP

Important dates

Study start
2007
Primary completion
2008
Study completion
2011
First posted
Jan 6, 2009
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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