Clinical trial NCT00196053: The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery
Official title: Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Intrathecal pain management
constant flow pump
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Pain management measured by the visual analog pain scale
timeFrame: Quarterly for 1 year post-implant
measure: Pain management measured by quality of life score (SF-36)
timeFrame: Quarterly for 1 year post-implant
Secondary outcomes:
measure: Device-related adverse events over the duration of the study
timeFrame: End of trial
Other outcomes:
Locations:
city: Laon
country: France
city: Bamberg
country: Germany
city: Freiburg
country: Germany
city: Konstanz
country: Germany
city: Meppen
country: Germany
city: Tutzing
country: Germany
city: Middlesbrough
country: United Kingdom
city: Plymoth
country: United Kingdom
Study officials:
affiliation: Unaffilliated
name: Michael Ward, DVM
role: STUDY_DIRECTOR
References: