Augmented Reality for Subdural Drain Placement

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subdural Hematoma
• Intervention / Treatment: Device: Augmented Reality Device

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria

• Unable to have CT scan
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot Usability (Part 1); 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.	Device: Augmented Reality Device; AR device will be used to determine where to place SEPS drain
Experimental: AR Guided SEPS Placement (Part 2); AR guidance is used to place SEPS drain	Device: Augmented Reality Device; AR device will be used to determine where to place SEPS drain
No Intervention: Anatomical Guided SEPS Placement (Part 2); Standard of care, non AR guided SEPS drain placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in size (mm) of subdural hematoma	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.	Pre-procedure and 24 hours after SEPS placement
Change in symptom score	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.	Assess at 24 hours status post SEPS placement and again at 1 month
Length of hospital stay	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.	Approximately 2 to 5 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Vivek P Buch, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: 70606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No