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NCT00197392 · ClinicalTrials.gov registry record · Phase 4
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
A Phase 4 study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage, sponsored by Codman & Shurtleff.
- Completed
- Registry status
- Phase 4
- Development phase
- 434
- Enrollment target
- 20
- Study locations
NCT00197392: Completed Phase 4 study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage, sponsored by Codman & Shurtleff.
NCT00197392 is a Phase 4 study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage that has completed, run by Codman & Shurtleff. The registered enrollment target is 434 participants, below the 3,567-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00197392, a Phase 4 study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage, has completed, sponsored by Codman & Shurtleff.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 434 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study
Primary Outcome
The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
Conditions Studied
Interventions
- DEVICE Bactiseal TM EVD
- DEVICE Standard EVD Catheter
Study Locations (20)
Other
- Tiantan Hospital - Beijing
- Xuan Wu Hospital - Beijing
- - Angers
- - Lille
- - Paris
- Prince of Wales Hospital - Hong Kong
- Queen Mary Hospital - Hong Kong
- - Oslo
- National Neuroscience Institute - Singapore
- Singapore General Hospital - Singapore
- - Bristol
- - Leeds
- - Salford
Alberta
- - Calgary
- - Edmonton
California
- - Los Angeles
Florida
- - Gainesville
New York
- - Syracuse
Pennsylvania
- - Hershey
Quebec
- - Sherbrooke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2004-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
What the finished NCT00197392 record still lists
NCT00197392 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, below the 3,567-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Bactiseal TM EVD is the first listed.
NCT00197392 names 20 study sites across 7 states, led by Other, Alberta, California.
Frequently Asked Questions
What is clinical trial NCT00197392 about?
NCT00197392 is a clinical study titled "Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System". The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL o...
What is the current status of trial NCT00197392?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 434 participants. The study started on 2004-11. Estimated completion is 2010-01.
What conditions does trial NCT00197392 study?
This clinical trial studies the following conditions: Subarachnoid Hemorrhage, Intraventricular Hemorrhage.
What interventions are being tested in trial NCT00197392?
The interventions under investigation include: Bactiseal TM EVD (DEVICE), Standard EVD Catheter (DEVICE).
Who is sponsoring clinical trial NCT00197392?
This trial is sponsored by Codman & Shurtleff, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00197392 being conducted?
This trial has 20 study locations across California, Florida, New York, Pennsylvania, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00197392's enrollment target sits among peer trials
434 5th of 21 higher than 17 of 21 other Subarachnoid Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Subarachnoid Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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