Holographic Screens as a Replacement of Monitors During GI Endoscopies

Study Overview
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Brief Summary
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Nowadays, the application and development of spatial technologies have shown an increased interest in different fields of medicine, especially in procedural specialties. Many studies have shown the utility of augmented and virtual reality; however, studies evaluating mixed reality are scarce. In gastroenterology, some proposed advantages of MR are the 3D space guidance, its increased situational awareness, remote assistance, and the reduction of surgical monitors in the units. Based on this, the researchers proposed a multicenter trial to assess the added value of MR through a holographic device during gastroenterology endoscopic procedures.

Detailed Description
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In the medical field, many technologies have emerged to aid healthcare providers during training, communication, and management of patients. The area of spatial computing is becoming part of the immersive developing technology. The main components of spatial computing are augmented, virtual, and mixed reality (AR, VR, and MR, respectively). VR is a human-computer interface that simulates a realistic environment, while AR superimpose elements of VR in a real-world environment. AR is an enhanced version of the real-world achieved through sensory information delivered via technology. Moreover, the combination of both is known as MR. Mixed reality is an interactive, real-time processed, three-dimension registered technology. In medicine, published data has broadly demonstrated the utility and advantages of AR and VR in many fields like neurosurgery, cardiology, maxillofacial, hepatobiliary, and orthopedics. However, information about MR for health purposes is scarce. Based on the above, it is necessary to develop studies to assess the utility of MR in other procedural medical fields like gastroenterology. Some of the proposed advantages of MR in gastroenterology, mainly during endoscopic procedures, are the 3D space guidance and gesture operation (translation and rotation) without touching the object, the increase in situational awareness by reduction of real-world and content refocusing, the remote assistance during procedures, and the replacement/reduction of the use of monitors during the procedures. To evaluate the advantages and added value of MR in gastroenterology, the researchers proposed a multicenter trial in the endoscopic units by using a built developed application (HXtendTM, mdconsgroup, Guayaquil, Ecuador) for the HoloLens2TM (Microsoft, Redmond, WA, USA) holographic device.

Official Title
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Mixed-reality Holographic Screens as the Replacement of Monitors in the Endoscopy Suite: a Multicenter Study

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Device: Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Expert gastrointestinal endoscopists performing diagnostic colonoscopy, cholangioscopy, ERCP or EUS evaluation/intervention Written informed consent provided Exclusion Criteria: Refuse to participate in the study or to sign corresponding informed consent Internet connection less than 100 MBs per second.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: A non-blinded, multicenter, non-randomized prospective trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopy procedure + mixed reality<br>This group is comprised by expert gastrointestinal endoscopists designated to perform diagnostic procedures. The procedure will be performed without physical surgical monitors, and through the guidance of Mixed Reality by using the HXtend™ application holographic monitors. | Device: Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software)<br>* Included expert gastrointestinal endoscopists performing diagnostic procedures with mixed reality guidance. All the procedures will be performed by using the HoloLens2TM (Microsoft, Redmond, WA, USA), an ergonomic self-contained holographic device. HoloLens2TM (Microsoft, Redmond, WA, USA) uses HXtend™ developed software (mdconsgroup, Guayaquil, Ecuador) installed and running on Windows holographic OS. The monitors signals are replicated into holograms by an app developed with the unity Software package (Version 2022.1.22, Unity Technologies, San Francisco, CA, USA). After each procedure, the researchers will evaluate the device performance along with the acceptance and experience of the endoscopists using this technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User´s device experience during real-time endoscopic procedures | After performing the endoscopic procedure with mixed reality, the expert endoscopist´s experience will be evaluated. The investigators will use a Likert's scale to assess user´s experience (comfort, functionality, and learnability). | Up to four hours | 
| Image quality during visualization of anatomical structures | The quality of image during the endoscopic procedure (hologram and surgical field) will be assess through perceptual judgment of the user by using a Likert scale. | up to three hours | 
| Device-based measured latency during endoscopic procedures | Latency, as a measurement of the time it takes to the data to travel from one node to the other, will be measured by the device´s developed software using a networking library. The software will display the network metrics of the transmission. The latency will be measured in milliseconds. | Up to three hours | 
| Video processors interoperability | Interoperability, as the ability of computerized products to readily connect and exchange information with one another, will be measured between multiple video processors (Boston Scientific, Micro-tech and Pentax Medical) and the HoloLens2. Its assessment will be made by measuring the latency (ms) and the frames per second (FPS). | up to three hours | 
| Interconnectivity | Interconnectivity, as the connection between to HoloLens through the HXtend™, and the use of gestures from one HoloLens displayed in the second HoloLens, will be assessed by measuring the latency in milliseconds. | Up to three hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented reality, endoscopy, gastrointestinal, virtual reality, mixed reality