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Search / Trial NCT07042048

Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization

Launched by THE COOPER HEALTH SYSTEM · Jun 25, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Evd Augmented Reality Tbi Ich Image Guidance

ClinConnect Summary

This clinical trial is studying a new way to help place a small tube called an external ventricular drain (EVD) into the brain. This tube helps drain extra fluid or blood in adults who have serious brain injuries, like bleeding inside the brain (intracerebral or intraventricular hemorrhage) or severe head trauma. The trial wants to find out if using augmented reality—a technology that adds computer images onto what the doctor sees—can be just as safe and effective as the usual method that uses detailed brain scans to guide the placement of the drain.

Adults between 65 and 74 years old who are admitted to Cooper University Health with these brain injuries and need an EVD might be eligible. To join, patients must have certain signs on brain scans or low scores on a coma scale, showing serious injury. People with other brain problems, those already in other experimental studies, or those who can’t follow the study rules won’t be able to participate. If selected, patients will receive the EVD placement using either augmented reality or the standard imaging method, and the doctors will carefully watch to see how well and safely the drain is placed. This study aims to improve how doctors use technology to help treat serious brain injuries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • adult patient at time of screening
  • diagnosis of spontaneous ICH with IVH with severe TBI
  • * Meet one or more of the following clinical or radiographic criteria:
  • Tissue swelling on imaging Dysmorphic ventricles on imaging Midline shift \>2mm on imaging Mass effect on imaging Evans Index \<0.3 on imaging Glasgow Coma Scale 3-8
  • admitted to Cooper University Health
  • requires an EVD
  • Exclusion Criteria:
  • Other concomitant intracranial pathology (e.g., tumor, tumor-related edema/hemorrhage, congenital condition, etc.)
  • Concurrent participation in another research protocol for investigation of an experimental therapy
  • Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the investigator

About The Cooper Health System

The Cooper Health System is a leading academic healthcare organization dedicated to delivering high-quality clinical care, advancing medical research, and providing education in the health sciences. With a robust network of hospitals, outpatient facilities, and specialized care centers, Cooper is committed to improving patient outcomes through innovative treatments and cutting-edge clinical trials. The system's research initiatives focus on a wide range of medical disciplines, fostering collaboration among healthcare professionals and academic institutions to enhance evidence-based practices and contribute to the advancement of medical knowledge.

Locations

Camden, New Jersey, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported