ARCHIMEDES Compassionate Use Supplement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Keywords

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Implantable pump Intrathecal catheter Constant flow pump

Interventions

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Archimedes Constant Flow Pump & System

Pump implanted in abdomen with intrathecal delivery (catheter) for pain.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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South Side Pain Solutions

Danville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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DDS-US02-001

Identifier Type: -

Identifier Source: org_study_id