The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery|
- Pain management measured by the visual analog pain scale [ Time Frame: Quarterly for 1 year post-implant ] [ Designated as safety issue: No ]
- Pain management measured by quality of life score (SF-36) [ Time Frame: Quarterly for 1 year post-implant ] [ Designated as safety issue: No ]
- Device-related adverse events over the duration of the study [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Pain management has been a long-standing challenge to the medical community, specifically for the treatment of chronic pain. Chronic Pain is defined by the American Chronic Pain Association as "pain that continues a month or more beyond the usual recovery period for an illness or injury or pain that goes on over months or years as a result of a chronic condition." Chronic pain affects the patient's quality of life, work performance and attendance, mental health, social interactions and overall activities of daily living.
Implantable pumps were used for cancer and non-cancer patients, who had pain, which was resistant to conventional therapy. Intrathecal morphine administration is now accepted as a safe and effective method of controlling or reducing pain and its impact on the sufferer.
The Codman ARCHIMEDES Implantable Constant-Flow Infusion Pump is CE marked, and has been commercially available in Europe for intrathecal delivery of morphine and baclofen since August 1997. ARCHIMEDES is intended for the treatment of chronic intractable (cancer or non-cancer) pain, which requires chronic intrathecal infusion of preservative-free morphine sulfate.
This is a European, multicenter, prospective, single arm, observational registry conducted on a total of 150 Subjects at up to 10 centers in Europe.
Subjects will be followed at 3, 6, 9, and 12 months post Archimedes implant to assess their pain management and quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196053
|Laon, France, 02000|
|Bamberg, Germany, 81677|
|Freiburg, Germany, 79106|
|Konstanz, Germany, 78461|
|Meppen, Germany, 49704|
|Tutzing, Germany, 82327|
|Middlesbrough, United Kingdom, TS4 3BW|
|Plymoth, United Kingdom, PL6 8DH|
|Study Director:||Michael Ward, DVM||Unaffilliated|