Status:
COMPLETED
The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery
Lead Sponsor:
Codman & Shurtleff
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- The Subject has been suffering from chronic (benign and/or malignant) intractable pain for at least 2 or more months duration (pending national laws) with a pre-implant value equal or more than 7 on the Visual Analog Pain Scale.
- The subject does not tolerate oral pain medication at the required therapeutic dose to treat his/her pain.
- The Subject has a minimum reasonable life expectancy of at least 6 months.
- The Subject has given written Informed Consent prior to enrollment into this study.
- The body size of the Subject is sufficient to accept the pump bulk and weight, per the Principal Investigator's discretion.
- The Subject is willing to participate in this registry for 1 year post implant and is willing to comply with the investigational plan requirements.
- It is the Principal Investigator's judgment, based on the knowledge of the Subject, and Subject's condition, as well as the features of the implantable system that the Subject is an appropriate candidate for pain management utilizing an implantable pump for continuously delivering preservative-free morphine sulfate via an intrathecal route.
Exclusion
- The Subject has a skin condition (i.e., scleroderma, psoriasis, rash, or open wound) at the site chosen for implantation that would compromise the integrity or access to the injection port.
- The Subject has previously enrolled in or participated in an investigational drug or device trial within the preceding 4 weeks.
- The Subject has any known contraindication to preservative-free morphine sulfate.
- The Subject has a suspected or documented allergy to preservative-free morphine sulfate or related drugs.
- The Subject has a suspected or documented allergy to the materials of the infusion pump or catheter(s) (for example, silicone).
- The Subject has a history of drug and/or alcohol abuse per Principal Investigator discretion.
- The Subject is a female who is pregnant or lactating.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00196053
Start Date
March 1 2005
End Date
August 1 2007
Last Update
May 2 2012
Active Locations (8)
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1
Laon, France, 02000
2
Bamberg, Germany, 81677
3
Freiburg im Breisgau, Germany, 79106
4
Konstanz, Germany, 78461