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

NCT03921385 | Completed

• 1 other identifier: 828346
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single cohort - navigated cranial and spine surgery

Device: Augmented Reality Headset

Interventions

Augmented Reality Headset DEVICE

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.

Single cohort - navigated cranial and spine surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19101, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: April 19, 2019
• Study Start: February 22, 2018
• Primary Completion: January 18, 2019
• Study Completion: July 14, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)