Trial record 1 of 1 for:    NCT00817596
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Prometra's Utilization in Mitigating Pain (PUMP) (PUMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817596
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : July 31, 2012
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intractable Pain Device: Infusion Pump (Prometra) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prometra's Utilization in Mitigating Pain (PUMP)
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2011

Intervention Details:
    Device: Infusion Pump (Prometra)
    Implantation of pump/catheter for infusion of morphine into the intrathecal space
    Other Name: Prometra

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817596

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
Sponsors and Collaborators
Flowonix Medical

Responsible Party: Flowonix Medical Identifier: NCT00817596     History of Changes
Other Study ID Numbers: G060192
First Posted: January 6, 2009    Key Record Dates
Results First Posted: July 31, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Pain, Intractable
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms