Augmented Reality Enhanced Surgery: Use of Holographic Technology in Cranial and Spinal Surgery (ARinOR)

Augmented Reality Enhanced Surgery: Proof-of-concept Study for the Use of Holographic Technology in Cranial and Spinal Surgery

• To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field.
• To develop a systematic, efficient communication and registration process allowing holographic technology to be potentially utilized as a navigation tool in cranial and spinal neurosurgery. This entails developing software, optimizing connection parameters, and devising registration techniques incorporating line-of-sight fiducial markers to allow the holographic device to function as a navigation instrument.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Augmented Reality Headset

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19101
      • University of Pennsylvania Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient undergoing an elective cranial or spinal procedure at the University of Pennsylvania, Department of Neurosurgery.

Description

Inclusion Criteria:

• age >= 18
• must be able to read and understand English, and sign the informed consent form

Exclusion Criteria:

• emergent/emergency procedures
• pediatric patients
• pregnant patients
• vulnerable populations

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single cohort - navigated cranial and spine surgery

Device: Augmented Reality Headset; Patients undergoing navigated cranial or spine procedures will acquire standard of care clinical high-resolution imaging to be used for registration purposes intraoperatively. VGA output on the navigation machine will be utilized to project imaging information to the augmented reality headset. The holographic image will then be recorded to assess feasibility and ease of use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of holographic technology in the operating room using a feasibility scale ranging from 1-10	To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field.	2 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 828346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No