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Procedure

Augmented Reality for Subdural Hematoma

N/A

Waitlist Available

Led By Vivek P Buch, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assess at 24 hours status post seps placement and again at 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial uses AR to help accurately place a medical device in the brain, comparing it to traditional methods.

Who is the study for?

This trial is for individuals with a subdural hematoma, which is a type of brain bleed that requires drainage. Participants must be candidates for a procedure using the Subdural Evacuating Portal System (SEPS). They cannot join if they are unable to undergo CT scans or if they are pregnant.

What is being tested?

The study tests an Augmented Reality (AR) system designed to improve the accuracy of placing SEPS in patients with subdural hematomas. Initially, all participants will have both AR-guided and non-AR-guided skin markings compared for precision. Then, they'll be randomly assigned to actually receive SEPS placement either with or without AR guidance.

What are the potential side effects?

While specific side effects related to the use of the AR device itself may not be significant, typical risks associated with SEPS placement include infection risk at the site of surgery, potential bleeding during or after the procedure, and discomfort at the marked sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a brain bleed that will be treated with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assess at 24 hours status post seps placement and again at 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assess at 24 hours status post seps placement and again at 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and assess at 24 hours status post seps placement and again at 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean accuracy (in mm) of SEPS placement

Secondary study objectives

Change in size (mm) of subdural hematoma

Change in symptom score

Length of hospital stay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pilot Usability (Part 1)Experimental Treatment1 Intervention

Five patients will be enrolled to test whether the AR device functions appropriately, but no clinical decisions or changes to care will be determine by the AR device at this point.

Group II: AR Guided SEPS Placement (Part 2)Experimental Treatment1 Intervention

AR guidance is used to place SEPS drain

Group III: Anatomical Guided SEPS Placement (Part 2)Active Control1 Intervention

Standard of care, non AR guided SEPS drain placement

0 / 1Eligibility criteria met