NCT06052124

Augmented Reality for Subdural Drain Placement

Merging Augmented Reality and Neuroimaging to Improve Patient Safety and Outcomes for Neurosurgical Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Detailed description

Chronic/subacute subdural hematoma (SDH) is one of the most common diseases encountered in neurosurgical practice. However, there is little consensus on first-line treatment. The SEPS was developed to implement a minimally invasive approach to drainage. New imaging technologies, such as augmented reality (AR) interfaces, can provide anatomical models and can help visualize hidden structures. The hope is that this study can give insight on whether AR-guidance can be used to improve SEPS placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.

Conditions

• Subdural Hematoma

Interventions

Type	Name	Description
DEVICE	Augmented Reality Device	AR device will be used to determine where to place SEPS drain

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-09-25
• Last updated: 2023-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study