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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 5, 2009
Last Updated Date	August 13, 2012
Start Date ^ICMJE	January 2007
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 13, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: January 5, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00817596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prometra's Utilization in Mitigating Pain (PUMP)
Official Title ^ICMJE	Prometra's Utilization in Mitigating Pain (PUMP)
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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Intractable Pain
Intervention ^ICMJE	Device: Infusion Pump (Prometra) Implantation of pump/catheter for infusion of morphine into the intrathecal space Other Name: Prometra
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Completion Date	March 2011
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00817596
Other Study ID Numbers ^ICMJE	G060192
Has Data Monitoring Committee	No
Responsible Party	Flowonix Medical
Study Sponsor ^ICMJE	Flowonix Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Flowonix Medical
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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