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Augmented Reality for Subdural Drain Placement

NCT06052124 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-25

No results posted yet for this study

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

Interventions

DEVICE

Augmented Reality Device

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

Sponsors & Collaborators

Principal Investigators

  • Vivek P Buch, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052124 on ClinicalTrials.gov