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OpenTrials
Completed

NCT Number: NCT03921385

Augmented Reality Enhanced Surgery: 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.

Completed

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19101, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of holographic technology in the operating room using a feasibility scale ranging from 1-10

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: ARinOR

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Apr 19, 2019
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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