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NCT Number: NCT06253858

Ultrasound (US) Guided External Ventricular Catheter Placement

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Sara Craig Clinical Research Coordinator, BS, MNR

CONTACT

[email protected]

717-531-0003 ext. 285799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 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

    Time frame: 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

Other outcomes

  1. Length of time of the procedure

    Time frame: Up to three hours

    Number of minutes necessary to complete the procedure placement of the catheter

  2. Number of revision

    Time frame: up to 7 days

    Quantity of revisions due to the catheter malfunction

  3. Number of subjects with Cerebrospinal fluid (CSF) infection

    Time frame: up to 7 days

    CSF will be collected as part of standard of care after the procedure and tested for infection.

  4. Number of subjects with Superficial surgical site infection (SSI)

    Time frame: up to 7 days

    (The CDC defines SSI as deep and superficial. A superficial incisional SSI is an infection in the area of the skin where the incision was made. A deep incisional SSI occurs beneath the incision area in the muscle and the tissues surrounding the muscles. Signs to be monitored daily and put in a checklist will include redness, pain, unexplained fever source, pain, warmth, pus or swelling.)

  5. Longevity of the device function

    Time frame: up to 7 days

    Number of days until a subsequent catheter is placed

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Craig, MNR, BS

CONTACT

[email protected]

717-531-0003 ext. 285799

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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