ARCHIMEDES Compassionate Use Supplement

November 4, 2020 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.

Compassionate Use Supplement to the IDE Protocol to Determine Safety and Effectiveness of the ARCHIMEDES Implantable Constant-Flow Infusion Pump System

The purpose of this Compassionate Use Supplement to the IDE Protocol is to assure and monitor the safety of six Subjects (in the United States) implanted with ARCHIMEDES until all remaining implanted pumps are explanted.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Pain management has been a long-standing challenge to the medical community, specifically the treatment of chronic pain. On October 3, 2002, FDA approved Codman's IDE Study of Codman's Implantable Constant-Flow Infusion Pump System (ARCHIMEDES). The first Subject was implanted on February 12, 2003. Since then, ten Subjects have had the ARCHIMEDES implanted, with one Subject, implanted twice. Codman notified the FDA in 2004 that it wished to discontinue enrollment into the study & bring it to a close because of projected slow enrollment and waning physician interest.

Codman felt there was no readily acceptable alternate therapy that would not require a pump explant first. It is possible to replace the ARCHIMEDES with another pump system, which is already approved for use in the United States. However, such an action would necessitate the removal or explant of the ARCHIMEDES, thereby exposing the Subjects to additional risks inherent in such a surgical procedure, including those associated with anesthesia. Since these Subjects have been treated with the investigational device for at least 2 years without experiencing any unanticipated adverse device effects, Codman felt that the risk of explanting the pump was significantly greater than the risk of continuing treatment with the investigational device.

It should also be noted that this pump does not have a battery and that replacement is dictated by the number of times the septum is punctured (500). This translates into approximately twenty years of therapy if the septum is punctured an average of 20 times.

FDA approved Codman's Compassionate Use Protocol in 2005.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Danville, Virginia, United States, 24541
        • South Side Pain Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • U. S. Subjects implanted with constant flow pump in 2003.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DDS-US02-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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