Recruiting

SOLOPASS® System

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06253858

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Catheter Placement with Solopass System

Study Details

Brief 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.

Conditions

Hydrocephalus

Study ID

NCT06253858

Start date

Apr 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Catheter placement with Solopass system

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

Interventions

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 measure

  • Average number of passes needed to place the catheter in each subject. [ Time Frame: 0 minutes ]

Central Contacts and Locations

Central contacts

Sara Craig, MNR, BS

717-531-0003scraig2@pennstatehealth.psu.edu

Locations

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Sara Craig Clinical Research Coordinator, BS, MNR

717-531-0003Scraig2@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-06-05.