ARCHIMEDES Compassionate Use Supplement
Compassionate Use Supplement to the IDE Protocol to Determine Safety and Effectiveness of the ARCHIMEDES Implantable Constant-Flow Infusion Pump System
1 other identifier
expanded_access
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedNovember 6, 2020
October 1, 2020
April 16, 2008
November 4, 2020
Conditions
Keywords
Interventions
Pump implanted in abdomen with intrathecal delivery (catheter) for pain.
Eligibility Criteria
You may qualify if:
- U. S. Subjects implanted with constant flow pump in 2003.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Side Pain Solutions
Danville, Virginia, 24541, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 17, 2008
Last Updated
November 6, 2020
Record last verified: 2020-10