NCT00196053

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_4 chronic-pain

Timeline
Completed

Started Mar 2005

Typical duration for phase_4 chronic-pain

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

April 30, 2012

Conditions

Chronic Pain

Keywords

Intrathecal pain managementconstant flow pump

Outcome Measures

Primary Outcomes (2)

  • Pain management measured by the visual analog pain scale

    Quarterly for 1 year post-implant

  • Pain management measured by quality of life score (SF-36)

    Quarterly for 1 year post-implant

Secondary Outcomes (1)

  • Device-related adverse events over the duration of the study

    End of trial

Interventions

Archimedes Constant Flow Implantable PumpDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Laon, 02000, France

Location

Unknown Facility

Bamberg, 81677, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Konstanz, 78461, Germany

Location

Unknown Facility

Meppen, 49704, Germany

Location

Unknown Facility

Tutzing, 82327, Germany

Location

Unknown Facility

Middlesbrough, TS4 3BW, United Kingdom

Location

Unknown Facility

Plymoth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Ward, DVM

    Unaffilliated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 2, 2012

Record last verified: 2012-04

Locations

DE(5)GB(2)FR(1)