Augmented Reality for Subdural Drain Placement

Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052124
• Other study ID #: 70606
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria

• Unable to have CT scan

• Pregnancy

Related Conditions & MeSH terms

• Hematoma
• Subdural Hematoma

Intervention

Device:
• Augmented Reality Device
AR device will be used to determine where to place SEPS drain

Locations

Country	Name	City	State
United States	Stanford University Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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