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MalignancyNCT03328416

Augmented Reality Headset as Adjunct Display Monitor in AMIGO

A study testing Augmented Reality in people with Malignancy and Infection, run by Brigham and Women's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignancy, Infection, Pain
What is being tested?
Augmented Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient referred to one of the study co-investigators for a procedure that requires either: Pre-procedure planning that utilizes either CT or MR images; Intra-procedure imaging for the purpose of needle placement.

Who cannot join

  • Age under 18 at time of procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the detailed description

Augmented reality is a computer display technology that represents an incremental improvement over current computer monitors. Currently, a patient has a pre-procedure or intra-procedure CT or MRI scan and the scan images are displayed for the proceduralist on computer monitors in the procedure suite. Typically, only a single, or several selected, cross-sectional images can be viewed at a given time. With an augmented reality display headset, the pre-procedure and intra-procedure CT or MR images, including 3D reconstructions, can be displayed on transparent eyeglasses worn by the proceduralist. Moreover, the images are registered to the patient's location on the operating table and the images can be continuously updated to correspond with the body part in the proceduralist's field of view. Augmented reality display systems could thus decreased perceived work load of a procedure by allowing natural posture throughout the procedure, streamline and improve the clinical workflow, and provide the proceduralist with information in a manner that more readily facilitates three-dimensional understanding of the procedure.

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.

Being tested
Augmented Reality
Keywords
Image-Guided Biopsy, Multidetector Computed Tomography, Diagnostic Imaging, Cryosurgery, Ablation Techniques
Medical subject headings
Neoplasms, Infections, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented RealityDevice

    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.

Study groups in NCT03328416
Study groupRoleWhat they receive
Augmented RealityExperimentalThe neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
Receives: Device: Augmented Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scores from NASA Task Load Index (TLX) with supplemental questions to assess procedure strain

    The NASA TLX method assesses work load on five 7-point scales and the additional questions assess procedural strain on 7-point scales. Each 7-point scale item will be assessed independently. Total scores will also be summed and assessed. Higher scores translate to a higher work load (worse outcome).

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start1 Jan 2018
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Why it stopped: Expected technology was not available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328416
Sponsor's protocol ID
2017P001456
Status last verified
Jan 2020
First submitted
29 Oct 2017
Last updated
18 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Reality in people with Malignancy and Infection, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scores from NASA Task Load Index (TLX) with supplemental questions to assess procedure strain (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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