Holographic Screens as a Replacement of Monitors During GI Endoscopies

NCT05640401 | Unknown DMC

• 1 other identifier: IECED-11222022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Keywords

Augmented reality; endoscopy; gastrointestinal; virtual reality; mixed reality

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Endoscopy procedure + mixed reality

EXPERIMENTAL

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)

Interventions

Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software) DEVICE

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.

Endoscopy procedure + mixed reality

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expert gastrointestinal endoscopists performing diagnostic colonoscopy, cholangioscopy, ERCP or EUS evaluation/intervention
• Written informed consent provided

You may not qualify if:

• Refuse to participate in the study or to sign corresponding informed consent
• Internet connection less than 100 MBs per second.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead
• EndoscopyNet, Quito, Ecuador: collaborator
• mdconsgroup, Guayaquil, Ecuador: collaborator

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (5)

• 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.

  PMID: 32387499 BACKGROUND

• 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.

  PMID: 33565986 BACKGROUND

• 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.

  PMID: 34040777 BACKGROUND

• 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.

  PMID: 31867864 BACKGROUND

• 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.

  PMID: 33235047 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Carlos Robles-Medranda, MD FASGE

  Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Robles-Medranda, MD FASGE

CONTACT

+59342109180; carlosoakm@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non (open label)
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Model Details: A non-blinded, multicenter, non-randomized prospective trial.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 7, 2022
• Study Start: November 21, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

EC (1)