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Search / Trial NCT03696043

External Ventricular Drain Placement Stealth Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Oct 3, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Intracranial Pressure External Ventricular Drain Cerebrospinal Fluid

ClinConnect Summary

The External Ventricular Drain Placement Stealth Study is researching how to improve the placement of external ventricular drains (EVDs), which are tubes used to help manage pressure in the brain. These drains are often needed quickly in patients with serious neurological issues. Currently, doctors place these drains by using external landmarks on the head, but this method can lead to inaccuracies and complications. This study will compare the traditional freehand method with a new technique that uses advanced imaging technology called AxiEM Stealth, which helps guide EVD placement more accurately by mapping the patient’s unique head structure.

To be eligible for this study, participants must be adults aged 18 to 88 who require an EVD placement as decided by their doctor. They should also have a compatible CT or MRI scan of their head. Before joining the study, patients or their family members will need to give written consent. This study aims to improve how EVDs are placed, potentially leading to safer and more effective treatments for individuals facing serious brain conditions. Participants can expect close monitoring during the process, and their involvement will contribute to important research that could enhance care for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients undergoing bedside external ventricular drain placement determined by attending physician
  • Age ≥ 18 years and ≤ 88 years
  • Male or Female
  • Patients or consentable family member must sign a written informed consent prior to EVD placement
  • Stealth compatible head CT or MRI
  • Exclusion Criteria:
  • Patients ≤ 18 and ≥ 88 years of age
  • Prisoner status
  • Subjects who decline participation into the study
  • Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician
  • Patients who undergo emergent EVD placement via emergency consent
  • Subjects for whom self-consent or consent by a LAR cannot be obtained or cannot be obtained
  • Pregnant women
  • Non-English speaking patients

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Azam Ahmed, MD

Principal Investigator

University of Wisconsin, Madison

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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