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

CompletedPhase 4NCT00196053
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
Conditions
Interventions
  • Device: Archimedes Constant Flow Implantable Pump
Sponsor
Codman & Shurtleff
Start date
2005-03
Primary completion
2007-08
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
France, Germany, United Kingdom
Total sites listed
8

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00196053