Holographic Screens as a Replacement of Monitors During GI Endoscopies

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Enrolling

Conditions: Gastrointestinal Diseases

Treatments: Device: Endoscopy guided by mixed reality (HoloLens2TM) (HXtend™ software)

Study type: Interventional

Funder types: Other

Identifiers

NCT05640401

IECED-11222022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Endoscopy procedure + mixed reality

Experimental group

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.

Treatment:

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