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Ultrasound-Guided Catheter Placement for Hydrocephalus

This study is testing a device called the SOLOPASS® System. This system uses ultrasound (US) guidance to help doctors place a brain catheter more accurately into the brain's fluid-filled spaces (ventricles). The goal is to reduce the number of attempts needed to place the catheter correctly, prevent mistakes, and avoid the drain from not working properly. You may be able to join if you are 18 or older, have newly diagnosed hydrocephalus (a buildup of fluid in the brain), and meet certain health criteria, including having normal blood clotting and no active infections. The study is considered successful if the average number of passes needed to place the catheter is reduced. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 10 participants. It focuses on how well the SOLOPASS® System works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, the number of passes needed to place the catheter, is measured at 0 minutes.

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NCT06253858

Ultrasound (US) Guided External Ventricular Catheter Placement

Recruiting
NAAges 18+InterventionalTreatment
Milton S. Hershey Medical Center
~10 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Catheter Placement with Solopass System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average number of passes needed to place the catheter in each subject.
Measured over 0 minutes

Conditions

Hydrocephalus

Explore related trials

Hydrocephalus

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • J C Zacko, MD · PRINCIPAL_INVESTIGATOR · Milton S. Hershey Medical Center

Who to contact

Sara Craig, MNR, BS
[email protected]
717-531-0003 · ext. 285799
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.