Chronic Pain Clinical Trial
Official title:
Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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