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临床试验/NCT06282224
NCT06282224招募中不适用

Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery

The First Affiliated Hospital of Xiamen University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Postoperative complication

研究概览

简要总结

"For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery."

详细描述

  1. Research protocol The surgical AR neuroendoscopic system in this study mainly includes three core links: (1) virtual image or environmental modeling. AR systems use data derived from color or texture differences between anatomical structures in CT or MRI tomography, as well as whole-brain angiography, to complete a 3D reconstruction of a subsurface target in a computer. This process can also be done manually using the 3D-Slicer software. (2) Registration of virtual environment and real space. Registration technology is essential for AR systems, as it enables real-time tracking of anatomical structures in the endoscopic field of view. Registration can be done by a variety of means, such as the 3D Cartesian system, which is based on framing technology, which can determine the position and attitude of the imaging device, while also allowing the virtual environment to make rapid changes and register when the position changes in the real world. Or use frameless registration to register virtual match points with known anatomical landmarks in real space. (3) The final demand is to combine the virtual environment with the real environment to display technology. It can be divided into head-mounted display (HMD), enhanced external display, enhanced optical system, enhanced window display and image projection. Using HMDs to overlay virtual environments with video feeds from real environments (video perspective). Utilize a simple, stand-alone screen as an enhanced display to display virtual content on a video originating from a neuroendoscope.

After the above links are successfully achieved, transnasal skull base surgery is performed using neuroendoscope with AR to achieve real-time tracking, accurately identify anatomical structures, and reduce the risk of neurovascular injury and complications in skull base surgery.

Subjects: About 100 cases of neuroendoscopic skull base surgery performed in the Department of Neurosurgery of the First Affiliated Hospital of Xiamen University, regardless of gender and age.

Inclusion Criteria: 1. Patients undergoing transnasal endoscopic skull base surgery in our department. 2. Thin-slice head MRI and CTA scans were performed before surgery. Exclusion Criteria: 1. Patients without clear preoperative imaging data. 2. Patients who do not agree to receive AR fusion neuroendoscopic assistance. 3. Patients with incomplete medical records.

Intervention: Participants were divided into two groups to undergo transnasal skull base surgery using common neuroendoscopy and neuroendoscopy infused with augmented reality technology and compared.

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

surgery with AR-integrated endoscope

Experimental

Performing endoscopic transnasal skull base surgery with AR-integrated endoscope

干预措施: Performing endoscopic transnasal skull base surgery with AR-integrated endoscope (Device)

结局指标

主要结局

Postoperative complication

时间窗: at the time points of baseline,3 months, 6 months and 1 year after surgery

Postoperative complication including cerebrospinal fluid leakage, significant neurovascular injury, visual impairment, endocrine disorders, nasal septum perforation and postoperative diabetes insipidus.

Postoperative Recovery of Transnasal Surgery

时间窗: at the time points of baseline,3 months, 6 months and 1 year after surgery

Observe whether the preoperative symptoms (including endocrine abnormalities, impaired visual field, headache, etc.) were alleviated after surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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