Ultrasound (US) Guided External Ventricular Catheter Placement

Not Applicable

Not yet recruiting

• Conditions: Hydrocephalus
• Interventions: Device: Catheter Placement with Solopass System

• Registration Number: NCT06253858
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Study Start: 2025-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Decision made to perform the procedure by the primary consultant
• Age 18 or older
• Neuro ICU stay
• Newly diagnosed hydrocephalus
• Has a recent CT within the past 24 hrs
• Normal platelets and coagulation profile
• No active infection or currently on antibiotics
• The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging

Exclusion Criteria

• Age <18
• Not in Neuro ICU setting
• Previous placement of a ventricular catheter
• More than 50 percent of the fluid compartment is filled with blood by CT scan
• Time to include in the trial prohibited by clinical personnel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Catheter placement with Solopass system	Catheter Placement with Solopass System	The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter.

Primary Outcome Measures

Name	Time	Method
Average number of passes needed to place the catheter in each subject.	0 minutes	Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted.

Secondary Outcome Measures

Name	Time	Method
Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system	up to 7 days	Grade 1 means optimal placement in the ipsilateral frontal horn or third ventricle; Grade 2 means a functional placement in the contralateral lateral ventricle or no eloquent cortex; and Grade 3 means suboptimal placement in the eloquent cortex or nontarget cerebrospinal fluid space, with or without functional drainage