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Prometra's Utilization in Mitigating Pain (PUMP)

NCT ID: NCT00817596

Last Updated: 2012-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Intractable Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Infusion Pump (Prometra)

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

Intervention Type DEVICE

Other Intervention Names

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Prometra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flowonix Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pain Control Network

Louisville, Kentucky, United States

Site Status

Center for Pain Management

St Louis, Missouri, United States

Site Status

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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G060192

Identifier Type: -

Identifier Source: org_study_id