Augmented Reality Headset as Adjunct Display Monitor in AMIGO
NCT ID: NCT03328416
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-01-01
2019-12-30
Brief Summary
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Detailed Description
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The investigators' overarching goal is to investigate whether use of an augmented reality display system (utilized in addition to, not as a replacement to, conventional CT and MRI displays currently available in the procedure suite) streamlines the process of a procedure and/or provides ease of access to helpful pre-procedure and intra-procedure imaging information that would be more difficult and time-consuming to obtain with the conventional imaging display systems.
The three aims are as follows:
1. Determine if the augmented reality display system streamlines workflow.
2. Determine if the augmented reality display system decreases perceived work load.
3. Determine if the augmented reality display system facilitates access to helpful pre-procedure and intra-procedure imaging information as compared to traditional display systems.
The investigators hypothesize that the augmented reality display system will streamline workflow by reducing time required to stop the procedure to look away from the operative field to the conventional hanging monitor and then look back to the operative field and reorient to the operative field space.
The investigators hypothesize that the augmented reality display system will decrease perceived work load by reducing intra-procedure postural strain by projecting the images on a headset in addition to on traditional monitors hanging from the procedure-suite ceiling.
The investigators hypothesize that the augmented reality display system will facilitate access to helpful pre-procedure and intra-procedure imaging information because it will allow real-time projection of three-dimensional reconstructed images over the operative site with the images reflecting the point-of-view and field-of-view of the proceduralist. While this information can be generated and projected on traditional display systems, the positioning of the imaging is likely inferior as it can only mimic the point of view and field of view of the proceduralist.
All procedures will be performed in accordance with normal standard of care for the condition being treated. The only difference in care will be that the proceduralist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
A single REDCap survey will be sent to the performing co-investigator proceduralist (interventional radiologist or surgeon) following each procedure. The survey will include the NASA Task Load Index (TLX) to assess the work load associated with the procedure as well as several questions designed to determine if the NASA TLX score would likely have been higher or lower if the augmented reality system was not used and several questions designed to determine if the augmented reality system allowed visualization of imaging information in a way that was helpful in procedure planning or intraprocedural approach. The NASA TLX method assesses work load on five 7-point scales and the additional questions assess procedural strain on 7-point scales.
The primary outcome measures are the TLX scores. If these scores achieve statistical significance in one sample statistical tests then use of the augmented reality display will be considered successful. Although co-investigators will be subjects, the co-investigators have no relationship with the device maker and have no invested interest in using this device unless the device improves procedure efficiency and success; as such, it is unlikely that co-investigators as subjects will bias the results as the co-investigators will not want to utilize the device if it has a negative impact on workflow or if it increases perceived work load.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Augmented Reality
The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
Augmented Reality
The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
Interventions
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Augmented Reality
The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Thomas C. Lee
Assistant Professor of Radiology
Principal Investigators
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Thomas C Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2017P001456
Identifier Type: -
Identifier Source: org_study_id
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