Prometra's Utilization in Mitigating Pain (PUMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flowonix Medical
ClinicalTrials.gov Identifier:
NCT00817596
First received: January 5, 2009
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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 Intervention
Intractable Pain
Device: Infusion Pump (Prometra)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prometra's Utilization in Mitigating Pain (PUMP)

Further study details as provided by Flowonix Medical:

Primary Outcome Measures:
  • Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. [ Time Frame: 6 months - acute study ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 110
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Infusion Pump (Prometra)
    Implantation of pump/catheter for infusion of morphine into the intrathecal space
    Other Name: Prometra
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817596

Locations
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
  More Information

No publications provided

Responsible Party: Flowonix Medical
ClinicalTrials.gov Identifier: NCT00817596     History of Changes
Other Study ID Numbers: G060192
Study First Received: January 5, 2009
Results First Received: March 2, 2012
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014