An interventional study of Augmented Reality Device in Subdural Hematoma, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's planned enrollment of 100 is close to the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Exclusion Criteria
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 guidance is used to place SEPS drain
Device: Augmented Reality Device
Standard of care, non AR guided SEPS drain placement
AR device will be used to determine where to place SEPS drain
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.
Time frame: Intra-procedural and up to 24 hours post procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 2 to 5 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Dec 2025, 25 months later.
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This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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