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

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ClinicalTrials.gov Identifier: NCT03921385
Recruitment Status : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease
Surgery

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Augmented Reality Enhanced Surgery: Proof-of-concept Study for the Use of Holographic Technology in Cranial and Spinal Surgery
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921385


Locations
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United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19101
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03921385     History of Changes
Other Study ID Numbers: 828346
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No