Augmented Reality for Subdural Drain Placement

Not Applicable

Not yet recruiting

• Conditions: Subdural Hematoma
• Interventions: Device: Augmented Reality Device

• Registration Number: NCT06052124
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25
• Study Start: 2023-11
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Unable to have CT scan
• Pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AR Guided SEPS Placement (Part 2)	Augmented Reality Device	AR guidance is used to place SEPS drain
Pilot Usability (Part 1)	Augmented Reality Device	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.

Primary Outcome Measures

Name	Time	Method
Mean accuracy (in mm) of SEPS placement	Intra-procedural and up to 24 hours post procedure	Comparison of measurements obtained by standard of care surface measurements and placement using AR guidance, and post placement CT scans.

Secondary Outcome Measures

Name	Time	Method
Change in size (mm) of subdural hematoma	Pre-procedure and 24 hours after SEPS placement	Radiographic measure of thickest hematoma volume in sagittal and coronal planes after subdural evacuation compared to pre-procedure imaging, assessed in the randomized AR-guided and non-AR-guided arms only.
Change in symptom score	Assess at 24 hours status post SEPS placement and again at 1 month	Composite measure, scaled from 0 (no symptoms) to 10 (severe symptoms), scored by clinician based overall impression of objective and subjective signs and symptoms including neurological strength exam, cognitive status, and patient self-reported symptomatic change, assessed in the randomized AR-guided and non-AR-guided arms only.
Length of hospital stay	Approximately 2 to 5 days	Number of days since procedure between SEPS placement and discharge from inpatient stay, assessed in the randomized AR-guided and non-AR-guided arms only.

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States