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.
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
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:
- Determine if the augmented reality display system streamlines workflow.
- Determine if the augmented reality display system decreases perceived work load.
- 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
- Malignancy, Infection, Pain
- 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 group | Role | What they receive |
|---|---|---|
| Augmented Reality | Experimental | 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. Receives: Device: Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted1 Nov 2017
- Study start1 Jan 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Why it stopped: Expected technology was not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas C. Lee, Brigham and Women's Hospital
- Investigators
- Thomas C Lee, MD, Principal investigator, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Headset as Adjunct Display Monitor in AMIGO
- ClinicalTrials.gov ID
- NCT03328416
- Acronym / sponsor ID
- 2017P001456
- Conditions
- Malignancy, Infection, Pain
- Keywords
- Image-Guided Biopsy, Multidetector Computed Tomography, Diagnostic Imaging, Cryosurgery, Ablation Techniques
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Expected technology was not available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Determine if the augmented reality display system streamlines workflow.
- Determine if the augmented reality display system decreases perceived work load.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality | Experimental | Device: Augmented RealityThe neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Age under 18 at time of procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityThe neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling. | Device | Augmented Reality |
Primary outcome
Scores from NASA Task Load Index (TLX) with supplemental questions to assess procedure strain
Time frame: 15 minutes
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Lee, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
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.