跳至主要内容
临床试验/NCT05640401
NCT05640401招募中不适用

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

Instituto Ecuatoriano de Enfermedades Digestivas2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
2
主要终点
User´s device experience during real-time endoscopic procedures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

盲法说明

Non (open label)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

User´s device experience during real-time endoscopic procedures

时间窗: Up to four hours

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

时间窗: up to three hours

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.

Video processors interoperability

时间窗: up to three hours

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

时间窗: Up to three hours

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.

Device-based measured latency during endoscopic procedures

时间窗: Up to three hours

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.

次要结局

未报告次要终点

研究者

发起方
Instituto Ecuatoriano de Enfermedades Digestivas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Robles-Medranda

Head of the Endoscopy Division

Instituto Ecuatoriano de Enfermedades Digestivas

研究点 (2)

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