Augmented Reality for Subdural Drain Placement

NCT06052124 | Unknown FDA Device

• 1 other identifier: 70606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in size (mm) of subdural hematoma

  Pre-procedure and 24 hours after SEPS placement

• Change in symptom score

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

• Length of hospital stay

  Approximately 2 to 5 days

Study Arms (3)

Pilot Usability (Part 1)

EXPERIMENTAL

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 Guided SEPS Placement (Part 2)

EXPERIMENTAL

AR guidance is used to place SEPS drain

Device: Augmented Reality Device

Anatomical Guided SEPS Placement (Part 2)

NO INTERVENTION

Standard of care, non AR guided SEPS drain placement

Interventions

Augmented Reality Device DEVICE

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

AR Guided SEPS Placement (Part 2); Pilot Usability (Part 1)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to have CT scan
• Pregnancy

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Vivek P Buch, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Neurosurgery

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)