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

January 5, 2009
August 13, 2012
January 2007
March 2008   (final data collection date for primary outcome measure)
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.

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 ]
Complete list of historical versions of study NCT00817596 on ClinicalTrials.gov Archive Site
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Prometra's Utilization in Mitigating Pain (PUMP)
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intractable Pain
Device: Infusion Pump (Prometra)
Implantation of pump/catheter for infusion of morphine into the intrathecal space
Other Name: Prometra
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2011
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817596
G060192
No
Flowonix Medical
Flowonix Medical
Not Provided
Not Provided
Flowonix Medical
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP