Prometra's Utilization in Mitigating Pain II ((PUMP 2))
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00866164|
Expanded Access Status : Approved for marketing
First Posted : March 20, 2009
Last Update Posted : March 5, 2012
|Condition or disease||Intervention/treatment|
|Intractable Pain Back Pain Leg Pain Arm Pain Trunk Pain||Device: Prometra Programmable Pump|
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 Type :||Expanded Access|
|Official Title:||Prometra's Utilization in Mitigating Pain II|
- Device: Prometra Programmable Pump
Implantation of Prometra Pump for delivery of intrathecal morphine for the treatment of chronic intractable pain