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NCT03696043 · ClinicalTrials.gov registry record · NA
External Ventricular Drain Placement Stealth Study
A NA study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT03696043 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 31 participants.
The verdict
NCT03696043, a NA study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
External ventricular drain (EVD) placement is performed very often in neurosurgical practices. EVD's are most commonly placed at the bedside using external anatomical landmarks to guide the catheter into the frontal horn of the ipsilateral lateral ventricle. EVDs are often placed due to acute neurological compromise and require timely insertion. Accurate catheter placement is essential to achieving effective external CSF drainage without complications or occlusion/failure of the catheter. Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent. Current methods for EVD placement do not compensate for superficial brain vessels or pathology that may alter the intracranial anatomy such as trauma, hemorrhage, or mass lesions. Some studies have attempted to use CTA imaging to identify intracranial vessels in an attempt to avoid them during placement. Image guidance is a tool used very commonly for placement of EVD's and shunts in the operating room. AxiEM Stealth is a noninvasive image localization modality that registers a CT or MRI to the individual patients facial and scalp anatomy. This study will compare the current standard of care of freehand placement of bedside external ventricular catheters to the placement of EVD catheters with AxiEM Stealth image guidance.
Interventions
- OTHER Axium Steatlh Image Guidance
- OTHER EVD placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2026-03-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03696043
The ClinicalTrials.gov registry entry for NCT03696043 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Axium Steatlh Image Guidance is the first listed.
NCT03696043 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03696043 about?
NCT03696043 is a clinical study titled "External Ventricular Drain Placement Stealth Study". External ventricular drain (EVD) placement is performed very often in neurosurgical practices. EVD's are most commonly placed at the bedside using external anatomical landmarks to guide the catheter into the frontal horn of the ipsilateral lateral ventricle. EVDs are often placed due to acute neurol...
What is the current status of trial NCT03696043?
This trial is currently terminated. It is a NA study. The enrollment target is 31 participants. The study started on 2018-08-15. Estimated completion is 2026-03-12.
What interventions are being tested in trial NCT03696043?
The interventions under investigation include: Axium Steatlh Image Guidance (OTHER), EVD placement (OTHER).
Who is sponsoring clinical trial NCT03696043?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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