NCT00866164

Prometra's Utilization in Mitigating Pain II

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Flowonix Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain.

Detailed description

The development of fully implantable systems changed the dynamics and risks associated with intrathecal drug delivery. Pump reservoirs could be refilled with medication more infrequently (every 1-3 months), greatly reducing the risk of infection. Pumps were initially driven by the pressure differential of an injected gas, pushing drug at a fixed rate from an isolated chamber through an orifice of predetermined size. Later, mechanical pumps were developed that allowed for programmability of different infusion rates, and complex administration of infusions and preset boluses. These pumps have dominated the US market for long-term intrathecal drug delivery systems (IDDSs), and have expanded the range of conditions and patients that can be treated successfully. Because IDDSs characteristically deliver low flow rates of drug to the intrathecal space (\<1 mL/day), the reliability, durability, and accuracy of the pump are critical for the efficacy and safety of treatment. This continued access trial will assess the ongoing safety and efficacy of a new fully implanted IDDS, the Prometra Programmable Pump.

Conditions

• Intractable Pain
• Back Pain
• Leg Pain
• Arm Pain
• Trunk Pain

Interventions

Type	Name	Description
DEVICE	Prometra Programmable Pump	Implantation of Prometra Pump for delivery of intrathecal morphine for the treatment of chronic intractable pain

Timeline

• First posted: 2009-03-20
• Last updated: 2012-03-05