Augmented Reality for Subdural Drain Placement

Stanford University

Status

Not yet enrolling

Conditions

Subdural Hematoma

Treatments

Device: Augmented Reality Device

Study type

Interventional

Funder types

Other

Identifiers

NCT06052124

70606

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria

Unable to have CT scan
Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 3 patient groups

Pilot Usability (Part 1)

Experimental group

Description:

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.

Treatment:

Device: Augmented Reality Device

AR Guided SEPS Placement (Part 2)

Experimental group

Description:

AR guidance is used to place SEPS drain

Treatment:

Device: Augmented Reality Device

Anatomical Guided SEPS Placement (Part 2)

No Intervention group

Description:

Standard of care, non AR guided SEPS drain placement