Ultrasound (US) Guided External Ventricular Catheter Placement

Penn State Health

Status: Begins enrollment in 4 months

Conditions: Hydrocephalus

Treatments: Device: Catheter Placement with Solopass System

Study type: Interventional

Funder types: Other

Identifiers

NCT06253858

STUDY00022095

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Catheter placement with Solopass system

Experimental group

Description:

The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter.

Treatment:

Device: Catheter Placement with Solopass System