NCT00196053

The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery

Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management

Detailed description

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Archimedes Constant Flow Implantable Pump

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-09-20
• Last updated: 2012-05-02

Locations

8 sites across 3 countries: France, Germany, United Kingdom