Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052124
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-09-18
Brief Title:
Augmented Reality for Subdural Drain Placement
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Merging Augmented Reality and Neuroimaging to Improve Patient Safety and Outcomes for Neurosurgical Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
Chronicsubacute 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None