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Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

2014-08-27 03:16:34 | BioPortfolio

Summary

The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.

Description

The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. Lioresal Intrathecal (baclofen) is indicated for use in the management of severe spasticity. Spasticity is a major problem that has long challenged traditional medical treatment. While the incidence of spasticity is not known with certainty, it likely affects over half a million people in the United States and over 12 million worldwide. Spasticity is associated with some very common neurological disorders such as: multiple sclerosis, stroke, cerebral palsy, spinal cord and brain injuries. Chronic spasticity seriously restricts normal daily activities and reduces the quality of life for many patients.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Spasticity

Intervention

Prometra Programmable Implantable Pump System

Status

Not yet recruiting

Source

InSet Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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