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NCT06253858 | NOT YET RECRUITING | Hydrocephalus


Ultrasound (US) Guided External Ventricular Catheter Placement
Sponsor:

Milton S. Hershey Medical Center

Information provided by (Responsible Party):

Chris Zacko

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.

Condition or disease

Hydrocephalus

Intervention/treatment

Catheter Placement with Solopass System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Ultrasound (US) Guided External Ventricular Catheter Placement
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Ultrasound (US) Guided External Ventricular Catheter Placement

Location Details

NCT06253858


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