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Augmented Reality-Assisted Neurosurgical Drain Placement

NCT06571539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-08-26

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if high-accuracy augmented reality (AR) guidance for external ventricular drain (EVD) placement using a standalone head-worn navigation system can improve current shortcomings of freehand and image-guidance techniques. It will assess safety, feasibility and clinical performance. The main questions it aims to answer are:

* Is the implementation of a standalone head-worn AR navigation system for EVD placement in critical care settings feasible and safe?
* How does it compare to the conventional freehand technique in terms of EVD placement quality, complication rate and revision rate?

Researchers will assess placement quality using the modified Kakarla scale, grading placement quality based on the position of the EVD tip on postoperative CT imaging. The amount of attempts, complications and revisions will be documented. The results of the AR-guided placements will be compared to a matched, non-concurrent freehand control group.

Participants will undergo AR-guided EVD placement in a critical care setting (i.e. the emergency room or intensive care unit).

Conditions

  • Intracranial Hypertension

Interventions

DEVICE

AR-assisted EVD placement

Cfr. arm description

PROCEDURE

Freehand EVD placement

External ventricular drain (EVD) placement using the conventional freehand technique. This intervention covers the matched, non-concurrent control group, retrospectively obtained without active enrollment to receive study treatment.

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • Imec

    collaborator INDUSTRY

  • Orsi Academy

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-29
Primary Completion
2022-08-30
Completion
2023-08-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571539 on ClinicalTrials.gov