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

Surgery Clinical Trial

— ARinOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921385
• Other study ID #: 828346
• Status: Completed
• Start date: February 22, 2018
• Est. completion date: July 14, 2022

Study information

• Verified date: February 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 14, 2022
• Est. primary completion date: January 18, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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