NCT06253858 · Milton S. Hershey Medical Center
Ultrasound (US) Guided External Ventricular Catheter Placement
What this study is 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 effectiveness of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
View original scientific description
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.
Interventions
DEVICE
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Hershey, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations