Ultrasound (US) Guided External Ventricular Catheter Placement

NCT ID: NCT06253858

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Catheter placement with Solopass system

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

Group Type EXPERIMENTAL

Catheter Placement with Solopass System

Intervention Type 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.

Interventions

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Catheter Placement with Solopass System

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chris Zacko

Chris Zacko, MD Professor and Vice Chair for Quality, Department of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J C Zacko, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Central Contacts

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Sara Craig, MNR, BS

Role: CONTACT

717-531-0003 ext. 285799

Other Identifiers

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STUDY00022095

Identifier Type: -

Identifier Source: org_study_id

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