Prometra's Utilization in Mitigating Pain II — (PUMP 2)  

Back Pain Clinical Trial

Official title: Prometra's Utilization in Mitigating Pain II

Status Approved for marketing

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

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

• NCT number: NCT00866164
• Study type: Expanded Access
• Source: Flowonix Medical
• Status: Approved for marketing
• Phase: N/A