Ultrasound (US) Guided External Ventricular Catheter Placement

NCT06253858 | Recruiting FDA Device

• 1 other identifier: STUDY00022095
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Average number of passes needed to place the catheter in each subject.

  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.

  0 minutes

Secondary Outcomes (1)

• 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

Other Outcomes (5)

• Length of time of the procedure

  Up to three hours

• Number of revision

  up to 7 days

• Number of subjects with Cerebrospinal fluid (CSF) infection

  up to 7 days

Study Arms (1)

Catheter placement with Solopass system

EXPERIMENTAL

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

Device: Catheter Placement with Solopass System

Interventions

Catheter Placement with Solopass System DEVICE

This device is used as a guidance for placing a brain catheter to target the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.

Catheter placement with Solopass system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• J C Zacko, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Craig, MNR, BS

CONTACT

717-531-0003; scraig2@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chris Zacko, MD Professor and Vice Chair for Quality, Department of Neurosurgery

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

US (1)