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

This study has been completed.
Sponsor:
Information provided by:
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00196053
First received: September 13, 2005
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Chronic Pain
Device: Archimedes Constant Flow Implantable Pump
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Device-related adverse events over the duration of the study [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: March 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196053

Locations
France
Laon, France, 02000
Germany
Bamberg, Germany, 81677
Freiburg, Germany, 79106
Konstanz, Germany, 78461
Meppen, Germany, 49704
Tutzing, Germany, 82327
United Kingdom
Middlesbrough, United Kingdom, TS4 3BW
Plymoth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Study Director: Michael Ward, DVM Unaffilliated
  More Information

No publications provided

Responsible Party: Michael Ward, Worldwide Director, Clinical Research, Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00196053     History of Changes
Other Study ID Numbers: DDS-EU04-001, EU Pain Registry
Study First Received: September 13, 2005
Last Updated: April 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Codman & Shurtleff:
Intrathecal pain management
constant flow pump

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014