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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean accuracy (in mm) of SEPS placement

Secondary outcome measures

Change in size (mm) of subdural hematoma

Change in symptom score

Length of hospital stay

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,950 Total Patients Enrolled

Vivek P Buch, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age requirement for this experiment terminate at 75 years?

"Inclusion criteria for this clinical trial state that participants must be between the ages of 18-90. For those younger than 18, there are 3 separate studies available and 63 trials for patients aged 65 or higher."

Answered by AI

Does this trial currently require additional participants?

"According to clinicaltrials.gov, this trial is not recruiting at the present time; it was initially posted on November 1st 2023 and last updated on September 18th of the same year. Although there are currently no open positions for participants in this study, 64 other trials require enrolment now."

Answered by AI