Augmented Reality for Subdural Hematoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Unable to have CT scan, pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how augmented reality (AR) might help doctors place a subdural drain more accurately in patients with a subdural hematoma, a type of brain bleed. In the first part, researchers will assess the AR system's effectiveness by comparing it to standard methods without altering treatment. In the second part, patients will undergo either the AR-guided or the standard non-AR-guided procedure to determine which method is more effective. Individuals with a subdural hematoma scheduled for treatment with a subdural evacuating portal system (SEPS) and eligible for a CT scan might be suitable for this study. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance medical procedures.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this augmented reality system is safe for subdural drain placement?

Research has shown that using augmented reality (AR) in medical procedures, such as placing a subdural drain, appears promising. Studies have found that AR helps doctors perform these tasks more accurately, potentially reducing mistakes. For instance, one study found that AR-guided procedures were very precise, which could enhance the safety of placing drains.

Although the AR system does not directly treat a condition, it plays a crucial role in the procedure. By aiding doctors in placing the drain more accurately, it may lower the risk of complications associated with this type of surgery.

In summary, early findings suggest that using AR for placing drains is safe and well-tolerated by patients. This offers a hopeful outlook for those considering joining a trial involving this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using augmented reality (AR) for subdural drain placement because it could revolutionize how drains are placed in patients with subdural hematoma. Unlike the standard method that relies solely on anatomical guidance, AR provides real-time, 3D visualization, potentially improving precision and accuracy during the procedure. This innovative approach could lead to better patient outcomes by reducing the risk of complications and improving the overall success rate of drain placements. By integrating technology into surgical procedures, this method represents a significant leap forward in the treatment of subdural hematomas.

What evidence suggests that augmented reality is effective for subdural drain placement?

Research has shown that augmented reality (AR) can help doctors place brain drains more accurately, such as those used for subdural hematomas. One study demonstrated that AR successfully guided 11 drain placements on the first try, compared to a 64% success rate without AR. This trial will explore AR use in two parts. In the "Pilot Usability (Part 1)" arm, researchers will test the AR device for functionality without influencing clinical decisions. In the "AR Guided SEPS Placement (Part 2)" arm, AR guidance will assist in placing SEPS drains. Another report highlights how AR allows doctors to see imaging data directly on a patient's head, making it easier to find the right spot for draining. These findings suggest AR could make the procedure safer and more effective. ^{2 3 4 5 6}

Who Is on the Research Team?

Vivek Buch, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

Pregnancy

You cannot have a CT scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Usability

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

1 week

Treatment

Participants are randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Approximately 1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including symptom score assessment and radiographic measures.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality for Subdural Drain Placement

Trial Overview 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.

How Is the Trial Designed?

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

AR guidance is used to place SEPS drain

Group III: Anatomical Guided SEPS Placement (Part 2) Active Control 1 Intervention

Standard of care, non AR guided SEPS drain placement

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Subdural drains for chronic subdural hematoma (CSDH) evacuation have raised safety concerns, with misplacement rates reported as high as 17% in previous studies, indicating a need for careful consideration of drain placement techniques.

The effectiveness and safety of subdural drainage largely depend on the type of drain used and the surgical technique employed, suggesting that standardized methods, like those used in Denmark, may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drain type and technique for subdural insertion after burr hole evacuation of chronic subdural hematoma. Jensen, TSR., Poulsen, FR., Bergholt, B., et al.[2021]

In a study of 362 patients undergoing burr-hole drainage for chronic subdural hematoma, the modified Nelaton catheter (NC) technique significantly reduced the occurrence of brain contusions or new neurological deficits (1.8% vs. 10.5% with conventional technique).

The NC technique also resulted in fewer non-routine CT scans due to symptoms (5.4% vs. 36.5% with conventional technique), indicating a potential for reduced morbidity related to drain placement without compromising re-operation rates or overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing morbidity associated with subdural drain placement after burr-hole drainage of unilateral chronic subdural hematomas: a retrospective series comparing conventional and modified Nelaton catheter techniques. Moser, M., Coluccia, D., Watermann, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11132867/

clinical feasibility of augmented reality-navigated chronic ... The aim of this report is to highlight the feasibility and efficacy of a novel augmented reality (AR) overlay tool for surgical planning with ...

2. withpower.com withpower.com/trial/phase-hematoma-subdural-10-2023-55845

Augmented Reality for Subdural Hematoma Research shows that augmented reality (AR) can improve the accuracy of placing drains in the brain, which is similar to the procedure for subdural hematoma.

3. journals.lww.com journals.lww.com/neurosurgery/fulltext/2025/06000/high_accuracy_augmented_reality_guidance_for.8.aspx

High-Accuracy Augmented Reality Guidance for Intracranial... Eleven AR-guided EVD placements were performed, achieving functional placement in all cases on the first attempt, vs 7 (64%) in the control group (P = .045); ...

4. cureus.com cureus.com/articles/291887-aspiration-of-subdural-hygroma-using-augmented-reality-neuronavigation-a-case-report

Aspiration of Subdural Hygroma Using Augmented Reality ... For drainage of a subdural hygroma, AR can be used to superimpose imaging data directly onto the patient's head, allowing for precise ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11465702/

Aspiration of Subdural Hygroma Using Augmented Reality ... For drainage of a subdural hygroma, AR can be used to superimpose imaging data directly onto the patient's head, allowing for precise localization of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06052124

Augmented Reality for Subdural Drain Placement | ... This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS).