Nephrostomy; ComplicationsHolo-StreamNCT04774588
HoloStream Study - Video Capture Device Usage
A study testing VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada. in people with Nephrostomy; Complications and Fistula, run by University of Calgary.
Trial summary
Objectives: Primary Evaluate the primary operator usability of VSI streaming software for realtime streaming of images from video capture devices to a head mounted display (Hololens 2) during Interventional Radiology procedures Secondary Evaluate Radiographer usability of VSI streaming software. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrostomy; Complications, Fistula, Central Venous Catheter Thrombosis
- What is being tested?
- VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Apr 2022
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients requiring the following elective outpatient angiographic procedure are eligible for this study.
- These procedures include Nephrostomy tube replacement, Central venous access for line placement, Upper limb fistula access for angiography and associated procedures such as angioplasty or stent insertion, antegrade or retrograde Common Femoral Arterial access for angiography and associated procedures such as angioplasty or stent insertion.
- All patients must be 18 years of age or older.
- All patients must be able to provide written informed consent
Who cannot join
- Patients unable to provide written consent. Patients unwilling to provide written consent.
- Research participation is not in the best interest of the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Holographic Streaming of Input From Video Capture Devices During Interventional Radiology Procedures - a Feasibility Study (Hololens Study)
Objectives:
Primary
- Evaluate the primary operator usability of VSI streaming software for realtime streaming of images from video capture devices to a head mounted display (Hololens 2) during Interventional Radiology procedures Secondary
- Evaluate Radiographer usability of VSI streaming software.
- Develop suggestions for future research studies to assess the safety and efficacy of the VSI streamer software during other Interventional radiology procedures
- Evaluate the impact of VSI streaming software on room setup time, procedural time and fluoroscopy time
- Assess the feasability of remote collaboration by real time image transmission between remote devices through 3D telemedicine
Read the detailed description
The ergonomic design and setup of an operating/procedure room have long been a studied topic of interest. Back in 1999, an article (1) reviewed the ongoing research into the effects that operator posture, the operating room environment, and visualization of screens have on the ergonomics of surgery. They made the observation that 'future efforts to create a more user- friendly operating room environment will require the rethinking of traditional concepts of architecture, asepsis, and staffing (1). As technology rapidly advances, we are increasingly able to reassess and enhance the current ergonomic structure and setup of operating rooms and procedures.
Interventional radiology (IR) refers to a variety of minimally invasive procedures using small- caliber catheters under fluoroscopic or ultrasound guidance for the treatment of vascular and urologic, gastrointestinal conditions without the need for open surgery (2).
Interventional Radiology has the unique ergonomic consideration of the placement of the intraoperative viewing monitors (3). To perform any Interventional Radiology procedure, radiologists currently use a ceiling mounted or floor mounted image intensifier, a ceiling mounted screen and a small floor mounted monitor. In many procedures (usually those requiring downstream access into the vessel, arm or neck vascular access) the Radiologist has to move their own position to visualize all the screens, as it is impossible to rotate the screens adequately so that they are in a direct line with the Radiologists vision. Previous studies of office video terminal display (VDT) users demonstrate that the preferred viewing angle for VDTs is between 10° to 25° below the line of sight(4). The monitors are placed in such a way that the Interventional radiologist cannot possibly maintain the correct line of sight without some neck movement and craning. Inevitably, long periods of time standing in this awkward position can lead to musculoskeletal issues for the radiologist, as well as the stress of performing a procedure safely without the best line of vision.
The Interventional Radiologist is also wearing a heavy lead apron during the procedure, which adds to the ergonomic challenges. The incidence of neck and back pain increases with hours of apron use and years of practice, and may be the result of a combination of axial load (ie, prolonged standing in protective garments), awkward or poor posture (necessitated by leaning or bending to accomplish procedures), and repetitive injury accumulated over years of practice. (5)
In addition, there are multiple other screens monitoring patient parameters which are outside of the Interventional radiologist's field of view during the procedure, creating further safety concerns. Of note, other current concerns in the Interventional suite are costly screen breakage during manoeuvre of the screens during suite setup, and sterility issues that arise when the monitor is brought too close to the operating field.
The intention is that the new device will project a hologram of all the screens which can be positioned exactly in front of the operator at all times, irrespective of the patient position. Because it is mixed reality, the operator can still see their surroundings and perform the procedure exactly as normal.
With this technology, multiple screens of different modalities can be added, such as CT scans, MRI scans and 3D rendered holograms. Specific device instructions can also be visualized if necessary, without the requirement for the radiologist to leave the sterile procedure site.
The device can also be used to stream fluoroscopic and 3D images to a remote hololens or computer screen. This can be utilized for remote assistance and mentoring purposes. It will also be especially useful in the context of COVID-19, where reducing the clinical exposure of health care workers is of vital importance.
The main intention of the pilot study is to assess whether the hypothesis that the VSI streamer and HMD will indeed improve the ergonomics of the interventional suite sufficiently enough that the Interventional radiologist can perform the procedures more comfortably and safely. The practicalities of adding the VSI Streamer and HMD to the interventional suite setup will also be assessed.
During this initial pilot study, a practical assessment will be performed of the usability of the VSI streamer during commonly performed elective angiographic procedures. This will identify which procedures are particularly suited to this technology.
- Being tested
- VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.
- Medical subject headings
- Fistula, Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.Other
1.1 Description of VSI streamer device and software The VSI Streamer is a box that can be connected to ultrasound, endoscope, microscope, laparoscope and other devices via HDMI connection. The view of the imaging devices, which is conventionally displayed on a monitor, is transmitted wirelessly and in real time to the Mixed Reality HoloLens 2 (Microsoft Inc.) and appears as a virtual monitor that can be flexibly moved and positioned in space. Since this is Mixed Reality, the real environment remains visible. If required, several virtual monitors can be streamed into the Mixed Reality glasses at the same time
| Study group | Role | What they receive |
|---|---|---|
| Using VSI Streamer and Telemedicine Study | Other | Using the real time streaming of input from video capture devices to a head mounted display during interventional radiology procedures Receives: Other: VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada. |
| Not using VSI Streamer and Telemedicine Study | Placebo comparator | Not using real time streaming of input from video capture devices to a head mounted display and just using current standard imaging in the Interventional Suite. Receives: Other: VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the usability and effectiveness of VSI streaming software
- Evaluate the operator usability of VSI streaming software for realtime streaming of images from video capture devices to a head mounted display (Hololens 2) during Interventional Radiology procedures The NASA TLX questionnaire will be used to assess operator usability and effectiveness. Total score of the questionnaire items will be reported as medians and interquartile ranges and compared using non parametric Kruskal-Wallis and Mann-Whitney U tests as appropriate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrostomy; ComplicationsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Methodology: Single center randomized controlled pilot feasibility study. Firstly, VSI streamer software will be used for real time streaming of input from the fluoroscopy unit to a Head mounted display (Hololens 2) worn by the operator. This will be utilized to perform angiographic procedures on a 3D vascular model. Mock benchtop angiographic catheterization procedures will be performed in order to ensure practicality, safety and initial usability. Subsequently, appropriate patients undergoing elective Interventional Radiology procedures will be screened and enrolled. After performing these procedures on the first two patients, procedural parameters will be reviewed and subsequent patients will be enrolled if no safety concerns have arisen in the first two patients. Patients will be enrolled until a total of 60 procedures have been performed.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darshan Bakshi, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774588
- Sponsor's protocol ID
- REB21-0111
- Acronym
- Holo-Stream
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holographic Streaming of Input From Video Capture Devices During Interventional Radiology Procedures - a Feasibility Study (Hololens Study)
- ClinicalTrials.gov ID
- NCT04774588
- Acronym / sponsor ID
- Holo-Stream / REB21-0111
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 1 Mar 2021 (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.
Objectives:
Primary
- Evaluate the primary operator usability of VSI streaming software for realtime streaming of images from video capture devices to a head mounted display (Hololens 2) during Interventional Radiology procedures Secondary
- Evaluate Radiographer usability of VSI streaming software.
- Develop suggestions for future research studies to assess the safety and efficacy of the VSI streamer software during other Interventional radiology procedures
- Evaluate the impact of VSI streaming software on room setup time, procedural time and fluoroscopy time
- Assess the feasability of remote collaboration by real time image transmission between remote devices through 3D telemedicine
Detailed description
The ergonomic design and setup of an operating/procedure room have long been a studied topic of interest. Back in 1999, an article (1) reviewed the ongoing research into the effects that operator posture, the operating room environment, and visualization of screens have on the ergonomics of surgery. They made the observation that 'future efforts to create a more user- friendly operating room environment will require the rethinking of traditional concepts of architecture, asepsis, and staffing (1). As technology rapidly advances, we are increasingly able to reassess and enhance the current ergonomic structure and setup of operating rooms and procedures.
Interventional radiology (IR) refers to a variety of minimally invasive procedures using small- caliber catheters under fluoroscopic or ultrasound guidance for the treatment of vascular and urologic, gastrointestinal conditions without the need for open surgery (2).
Interventional Radiology has the unique ergonomic consideration of the placement of the intraoperative viewing monitors (3). To perform any Interventional Radiology procedure, radiologists currently use a ceiling mounted or floor mounted image intensifier, a ceiling mounted screen and a small floor mounted monitor. In many procedures (usually those requiring downstream access into the vessel, arm or neck vascular access) the Radiologist has to move their own position to visualize all the screens, as it is impossible to rotate the screens adequately so that they are in a direct line with the Radiologists vision. Previous studies of office video terminal display (VDT) users demonstrate that the preferred viewing angle for VDTs is between 10° to 25° below the line of sight(4). The monitors are placed in such a way that the Interventional radiologist cannot possibly maintain the correct line of sight without some neck movement and craning. Inevitably, long periods of time standing in this awkward position can lead to musculoskeletal issues for the radiologist, as well as the stress of performing a procedure safely without the best line of vision.
The Interventional Radiologist is also wearing a heavy lead apron during the procedure, which adds to the ergonomic challenges. The incidence of neck and back pain increases with hours of apron use and years of practice, and may be the result of a combination of axial load (ie, prolonged standing in protective garments), awkward or poor posture (necessitated by leaning or bending to accomplish procedures), and repetitive injury accumulated over years of practice. (5)
In addition, there are multiple other screens monitoring patient parameters which are outside of the Interventional radiologist's field of view during the procedure, creating further safety concerns. Of note, other current concerns in the Interventional suite are costly screen breakage during manoeuvre of the screens during suite setup, and sterility issues that arise when the monitor is brought too close to the operating field.
The intention is that the new device will project a hologram of all the screens which can be positioned exactly in front of the operator at all times, irrespective of the patient position. Because it is mixed reality, the operator can still see their surroundings and perform the procedure exactly as normal.
With this technology, multiple screens of different modalities can be added, such as CT scans, MRI scans and 3D rendered holograms. Specific device instructions can also be visualized if necessary, without the requirement for the radiologist to leave the sterile procedure site.
The device can also be used to stream fluoroscopic and 3D images to a remote hololens or computer screen. This can be utilized for remote assistance and mentoring purposes. It will also be especially useful in the context of COVID-19, where reducing the clinical exposure of health care workers is of vital importance.
The main intention of the pilot study is to assess whether the hypothesis that the VSI streamer and HMD will indeed improve the ergonomics of the interventional suite sufficiently enough that the Interventional radiologist can perform the procedures more comfortably and safely. The practicalities of adding the VSI Streamer and HMD to the interventional suite setup will also be assessed.
During this initial pilot study, a practical assessment will be performed of the usability of the VSI streamer during commonly performed elective angiographic procedures. This will identify which procedures are particularly suited to this technology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Methodology: Single center randomized controlled pilot feasibility study. Firstly, VSI streamer software will be used for real time streaming of input from the fluoroscopy unit to a Head mounted display (Hololens 2) worn by the operator. This will be utilized to perform angiographic procedures on a 3D vascular model. Mock benchtop angiographic catheterization procedures will be performed in order to ensure practicality, safety and initial usability. Subsequently, appropriate patients undergoing elective Interventional Radiology procedures will be screened and enrolled. After performing these procedures on the first two patients, procedural parameters will be reviewed and subsequent patients will be enrolled if no safety concerns have arisen in the first two patients. Patients will be enrolled until a total of 60 procedures have been performed.
| Arm | Type | Receives |
|---|---|---|
| Using VSI Streamer and Telemedicine Study | Other | Other: VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.Using the real time streaming of input from video capture devices to a head mounted display during interventional radiology procedures |
| Not using VSI Streamer and Telemedicine Study | Placebo comparator | Other: VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.Not using real time streaming of input from video capture devices to a head mounted display and just using current standard imaging in the Interventional Suite. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients requiring the following elective outpatient angiographic procedure are eligible for this study.
- These procedures include Nephrostomy tube replacement, Central venous access for line placement, Upper limb fistula access for angiography and associated procedures such as angioplasty or stent insertion, antegrade or retrograde Common Femoral Arterial access for angiography and associated procedures such as angioplasty or stent insertion.
- All patients must be 18 years of age or older.
- All patients must be able to provide written informed consent
Key exclusion criteria (2 listed)
- Patients unable to provide written consent. Patients unwilling to provide written consent.
- Research participation is not in the best interest of the patient.
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 |
|---|---|---|
| VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.1.1 Description of VSI streamer device and software The VSI Streamer is a box that can be connected to ultrasound, endoscope, microscope, laparoscope and other devices via HDMI connection. The view of the imaging devices, which is conventionally displayed on a monitor, is transmitted wirelessly and in real time to the Mixed Reality HoloLens 2 (Microsoft Inc.) and appears as a virtual monitor that can be flexibly moved and positioned in space. Since this is Mixed Reality, the real environment remains visible. If required, several virtual monitors can be streamed into the Mixed Reality glasses at the same time | Other | Not using VSI Streamer and Telemedicine Study, Using VSI Streamer and Telemedicine Study |
Primary outcome
Evaluate the usability and effectiveness of VSI streaming software
Time frame: 1 year
• Evaluate the operator usability of VSI streaming software for realtime streaming of images from video capture devices to a head mounted display (Hololens 2) during Interventional Radiology procedures The NASA TLX questionnaire will be used to assess operator usability and effectiveness. Total score of the questionnaire items will be reported as medians and interquartile ranges and compared using non parametric Kruskal-Wallis and Mann-Whitney U tests as appropriate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada. in people with Nephrostomy; Complications and Fistula, run by University of Calgary.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darshan Dr Bakshi, MD (4039919257, dbakshi@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the usability and effectiveness of VSI streaming software (time frame: 1 year). 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 1 Mar 2021.