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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: Clinical Trial NA study, sponsored by University of Wisconsin, Madison.

NCT03696043 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Collection of number of passes needed for successful catheter placement

Interventions

  • OTHER Axium Steatlh Image Guidance
  • OTHER EVD placement

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2018-08-15
Est. Completion 2026-03-12
Phase NA
University of Wisconsin, Madison

1,039 total trials

Why NCT03696043 stopped before completion

NCT03696043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Axium Steatlh Image Guidance is the first listed.

NCT03696043 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03696043's enrollment target sits among peer trials

31 1592nd of 2000 higher than 408 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03696043, the US trial registry maintained by the National Library of Medicine. NCT03696043 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.