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COMPLETED Phase 4

Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

NCT00197392 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 434 participants
Start Date 2004-11
Est. Completion 2010-01
Phase Phase 4

Sponsor

Codman & Shurtleff

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00197392

The ClinicalTrials.gov registry entry for NCT00197392 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 434 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Codman & Shurtleff, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00197392 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Alberta, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00197392?

The interventions under investigation include: Bactiseal TM EVD (DEVICE), Standard EVD Catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00197392?

This trial is sponsored by Codman & Shurtleff, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial