Augmented Reality for Subdural Drain Placement

NCT ID: NCT06052124

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Subdural Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Reality Device

Intervention Type DEVICE

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

AR Guided SEPS Placement (Part 2)

AR guidance is used to place SEPS drain

Group Type EXPERIMENTAL

Augmented Reality Device

Intervention Type DEVICE

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

Anatomical Guided SEPS Placement (Part 2)

Standard of care, non AR guided SEPS drain placement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Augmented Reality Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to have CT scan
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Vivek P. Buch

Assistant Clinical Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivek P Buch, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Hospital

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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70606

Identifier Type: -

Identifier Source: org_study_id

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