Holographic Screens as a Replacement of Monitors During GI Endoscopies

NCT ID: NCT05640401

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2023-10-30

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.

Conditions

Gastrointestinal Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Endoscopy procedure + mixed reality

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EndoscopyNet, Quito, Ecuador

UNKNOWN

Sponsor Role: collaborator

mdconsgroup, Guayaquil, Ecuador

UNKNOWN

Sponsor Role: collaborator

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

Sponsor Role: lead

Responsible Party

Carlos Robles-Medranda

Head of the Endoscopy Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Robles-Medranda, MD FASGE

Role: PRINCIPAL_INVESTIGATOR

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Locations

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, Guayas, Ecuador

Site Status: RECRUITING

Countries

Ecuador

Central Contacts

Carlos Robles-Medranda, MD FASGE

Role: CONTACT

carlosoakm@yahoo.es

+59342109180

Facility Contacts

Carlos Robles-Medranda, MD FASGE

Role: primary

carlosoakm@yahoo.es

+59342109180

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

IECED-11222022

Identifier Type: -

Identifier Source: org_study_id