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Search / Trial NCT06253858

Ultrasound (US) Guided External Ventricular Catheter Placement

Launched by MILTON S. HERSHEY MEDICAL CENTER · Feb 2, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new system called the SOLOPASS® System, which uses ultrasound technology to help place a special tube, known as an external ventricular drain, into the brain for patients with hydrocephalus. Hydrocephalus is a condition where fluid builds up in the brain, and this drain helps to remove that excess fluid. The goal of the trial is to see if this new system can more accurately place the drain, reducing the chances of mistakes and the need for multiple attempts.

To participate in the trial, individuals must be 18 years or older, currently staying in a Neuro ICU, and have just been diagnosed with hydrocephalus. They should also have had a CT scan within the last 24 hours that shows at least half of the fluid in the brain is cerebrospinal fluid (CSF) rather than blood. Participants in this trial can expect to have the ultrasound system used during their procedure, which aims to improve the placement of the drain and enhance their care. It’s important to know that the trial is not yet recruiting participants, and only those who meet specific criteria will be eligible to join.

Gender

ALL

Eligibility 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

About Milton S. Hershey Medical Center

Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported