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Augmented Reality for Subdural Drain Placement

Primary Purpose

Subdural Hematoma

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Augmented Reality Device

About this trial

This is an interventional treatment trial for Subdural Hematoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS Exclusion Criteria Unable to have CT scan Pregnancy

Sites / Locations

Stanford University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Pilot Usability (Part 1)

AR Guided SEPS Placement (Part 2)

Anatomical Guided SEPS Placement (Part 2)

Arm Description

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.

AR guidance is used to place SEPS drain

Standard of care, non AR guided SEPS drain placement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT06052124

First Posted

September 18, 2023

Last Updated

September 18, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT06052124

Brief Title

Augmented Reality for Subdural Drain Placement

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subdural Hematoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pilot Usability (Part 1)

Arm Type

Experimental

Arm Description

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.

Arm Title

AR Guided SEPS Placement (Part 2)

Arm Type

Experimental

Arm Description

AR guidance is used to place SEPS drain

Arm Title

Anatomical Guided SEPS Placement (Part 2)

Arm Type

No Intervention

Arm Description

Standard of care, non AR guided SEPS drain placement

Intervention Type

Device

Intervention Name(s)

Augmented Reality Device

Intervention Description

AR device will be used to determine where to place SEPS drain

Primary Outcome Measure Information:

Title

Mean accuracy (in mm) of SEPS placement

Description

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

Secondary Outcome Measure Information:

Title

Change in size (mm) of subdural hematoma

Description

Time Frame

Pre-procedure and 24 hours after SEPS placement

Title

Change in symptom score

Description

Time Frame

Assess at 24 hours status post SEPS placement and again at 1 month

Title

Length of hospital stay

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS Exclusion Criteria Unable to have CT scan Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek P Buch, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Hospital

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Augmented Reality for Subdural Drain Placement

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