HoloStream Study - Video Capture Device Usage

NCT04774588 | Unknown DMC

• 1 other identifier: REB21-0111
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.
• 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

Conditions

Nephrostomy; Complications; Fistula; Central Venous Catheter Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

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

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.

Other: VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.

Interventions

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

Not using VSI Streamer and Telemedicine Study; Using VSI Streamer and Telemedicine Study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients unable to provide written consent. Patients unwilling to provide written consent.
• Research participation is not in the best interest of the patient.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Fistula; Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Darshan Dr Bakshi, MD

CONTACT

4039919257; dbakshi@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Radiologist

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 1, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share