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Holographic Screens as a Replacement of Monitors During GI Endoscopies

Primary Purpose

Gastrointestinal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software)
Sponsored by
Instituto Ecuatoriano de Enfermedades Digestivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Gastrointestinal Diseases focused on measuring Augmented reality, endoscopy, gastrointestinal, virtual reality, mixed reality

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Ecuatoriano de Enfermedades Digestivas (IECED)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopy procedure + mixed reality

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
September 1, 2023
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
Collaborators
EndoscopyNet, Quito, Ecuador, mdconsgroup, Guayaquil, Ecuador
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1. Study Identification

Unique Protocol Identification Number
NCT05640401
Brief Title
Holographic Screens as a Replacement of Monitors During GI Endoscopies
Official Title
Mixed-reality Holographic Screens as the Replacement of Monitors in the Endoscopy Suite: a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
Collaborators
EndoscopyNet, Quito, Ecuador, mdconsgroup, Guayaquil, Ecuador

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
Keywords
Augmented reality, endoscopy, gastrointestinal, virtual reality, mixed reality

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A non-blinded, multicenter, non-randomized prospective trial.
Masking
None (Open Label)
Masking Description
Non (open label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopy procedure + mixed reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software)
Intervention Description
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.
Primary Outcome Measure Information:
Title
User´s device experience during real-time endoscopic procedures
Description
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).
Time Frame
Up to four hours
Title
Image quality during visualization of anatomical structures
Description
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.
Time Frame
up to three hours
Title
Device-based measured latency during endoscopic procedures
Description
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.
Time Frame
Up to three hours
Title
Video processors interoperability
Description
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).
Time Frame
up to three hours
Title
Interconnectivity
Description
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.
Time Frame
Up to three hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Robles-Medranda, MD FASGE
Phone
+59342109180
Email
carlosoakm@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD FASGE
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD FASGE
Phone
+59342109180
Email
carlosoakm@yahoo.es
First Name & Middle Initial & Last Name & Degree
Hannah Pitanga-Lukashok, MD
First Name & Middle Initial & Last Name & Degree
Juan Alcivar-Vasquez, MD
First Name & Middle Initial & Last Name & Degree
Maria Egas-Izquierdo, MD
First Name & Middle Initial & Last Name & Degree
Miguel Puga-Tejada, MD
First Name & Middle Initial & Last Name & Degree
Martha Arevalo-Mora, MD
First Name & Middle Initial & Last Name & Degree
Jorge Baquerizo-Burgos, MD
First Name & Middle Initial & Last Name & Degree
Domenica Cunto, MD
First Name & Middle Initial & Last Name & Degree
Raquel Del Valle, MD
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD FASGE
First Name & Middle Initial & Last Name & Degree
Juan C Mendez, Eng
First Name & Middle Initial & Last Name & Degree
Efrain Sanchez, MD
First Name & Middle Initial & Last Name & Degree
Fernando Jurado, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32387499
Citation
Zhang J, Zhu L, Yao L, Ding X, Chen D, Wu H, Lu Z, Zhou W, Zhang L, An P, Xu B, Tan W, Hu S, Cheng F, Yu H. Deep learning-based pancreas segmentation and station recognition system in EUS: development and validation of a useful training tool (with video). Gastrointest Endosc. 2020 Oct;92(4):874-885.e3. doi: 10.1016/j.gie.2020.04.071. Epub 2020 May 6. Erratum In: Gastrointest Endosc. 2021 Mar;93(3):781.
Results Reference
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PubMed Identifier
33565986
Citation
Yeung AWK, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J, Glisic M, Zeiner S, Kulnik ST, Crutzen R, Kimberger O, Kletecka-Pulker M, Atanasov AG, Willschke H. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021 Feb 10;23(2):e25499. doi: 10.2196/25499.
Results Reference
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PubMed Identifier
34040777
Citation
Reis G, Yilmaz M, Rambach J, Pagani A, Suarez-Ibarrola R, Miernik A, Lesur P, Minaskan N. Mixed reality applications in urology: Requirements and future potential. Ann Med Surg (Lond). 2021 May 13;66:102394. doi: 10.1016/j.amsu.2021.102394. eCollection 2021 Jun.
Results Reference
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PubMed Identifier
31867864
Citation
Verhey JT, Haglin JM, Verhey EM, Hartigan DE. Virtual, augmented, and mixed reality applications in orthopedic surgery. Int J Med Robot. 2020 Apr;16(2):e2067. doi: 10.1002/rcs.2067. Epub 2020 Feb 6.
Results Reference
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PubMed Identifier
33235047
Citation
Lee GK, Moshrefi S, Fuertes V, Veeravagu L, Nazerali R, Lin SJ. What Is Your Reality? Virtual, Augmented, and Mixed Reality in Plastic Surgery Training, Education, and Practice. Plast Reconstr Surg. 2021 Feb 1;147(2):505-511. doi: 10.1097/PRS.0000000000007595.
Results Reference
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Holographic Screens as a Replacement of Monitors During GI Endoscopies

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