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NCT00660556 Clinical Trial

ARCHIMEDES Compassionate Use Supplement

Pain Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00660556
Other study ID # DDS-US02-001
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date October 2020
Source Cerenovus, Part of DePuy Synthes Products, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - U. S. Subjects implanted with constant flow pump in 2003. Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Archimedes Constant Flow Pump & System
Pump implanted in abdomen with intrathecal delivery (catheter) for pain.

Locations
Country Name City State
United States South Side Pain Solutions Danville Virginia

Sponsors (1)
Lead Sponsor Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Country where clinical trial is conducted

United States, 

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