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Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light for Patients (Bullseye EVD) - Trial NCT05931991

Access comprehensive clinical trial information for NCT05931991 through Pure Global AI's free database. This phase not specified trial is sponsored by Sunnybrook Health Sciences Centre and is currently Recruiting. The study focuses on Intracranial Pressure Increase. Target enrollment is 15 participants.

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NCT05931991
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Trial Details
ClinicalTrials.gov โ€ข NCT05931991
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Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light for Patients (Bullseye EVD)
Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light

Study Focus

Observational

Sponsor & Location

Sunnybrook Health Sciences Centre

Toronto, Canada

Timeline & Enrollment

N/A

Jul 07, 2023

Mar 01, 2025

15 participants

Primary Outcome

Accuracy of the structured light computer vision system

Summary

The placement of external ventricular drainage (EVD) is a life-saving procedure used to
 relieve high pressures in the brain. Often performed at the bedside, a small tube (catheter)
 is inserted into one ventricle of the brain to drain cerebrospinal fluid and release the
 pressure build up. In standard practice, EVDs are placed freehand and initial catheter
 malpositioning occurs in up to ~60% of procedures. Currently, there are no adequate means to
 verify the position of the catheter before insertion which is a significant impediment to
 ensure accurate positioning. This non-interventional study aims to validate a novel
 technology, Bullseye EVD, for verifying the position of the EVD catheter during these
 emergency procedures.

ICD-10 Classifications

Benign intracranial hypertension
Intracranial injury
Intracranial injury, unspecified
Other intracranial injuries
Intracranial hypotension following ventricular shunting

Data Source

ClinicalTrials.gov

NCT05931991

Non-Device Trial