HydrocephalusNCT06253858
Ultrasound (US) Guided External Ventricular Catheter Placement
A study testing Catheter Placement with Solopass System in people with Hydrocephalus, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Catheter Placement with Solopass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Sara Craig Clinical Research Coordinator, BS, MNR, 717-531-0003 ext. 285799, Scraig2@pennstatehealth.psu.edu
About this study
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
- Being tested
- Catheter Placement with Solopass System
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Placement with Solopass SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Catheter placement with Solopass system | Experimental | The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter. Receives: Device: Catheter Placement with Solopass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Zacko, Milton S. Hershey Medical Center
- Investigators
- J C Zacko, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253858
- Sponsor's protocol ID
- STUDY00022095
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound (US) Guided External Ventricular Catheter Placement
- ClinicalTrials.gov ID
- NCT06253858
- Acronym / sponsor ID
- STUDY00022095
- Conditions
- Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter placement with Solopass system | Experimental | Device: Catheter Placement with Solopass SystemThe Solopass US system will be used during catheter placement procedure to guide the placement of the catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Placement with Solopass SystemThis 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. | Device | Catheter placement with Solopass system |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for Hydrocephalus
RecruitingPhase 2
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Hydrocephalus in Infants, Hydrocephalus Acquired
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J C Zacko, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Placement with Solopass System in people with Hydrocephalus, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Craig, MNR, BS (717-531-0003 ext. 285799, scraig2@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of passes needed to place the catheter in each subject. (time frame: 0 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.