Back Pain Clinical Trial
Official title:
Prometra's Utilization in Mitigating Pain II
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.
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.
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