Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Target registration error
研究概览
简要总结
The gold standard surgical treatment for benign nasosinus pathologies is endoscopic surgery. This surgery has experienced considerable growth over the last 30 years. Nevertheless, these techniques can potentially lead to serious complications, with risks of damaging adjacent structures (orbit, optic nerve, meninge or internal carotid artery). Therefore, improving the safety of these procedures is a fundamental objective. Recently, computer-assisted surgery, allowing endonasal navigation, has emerged. It appears to be an asset for the patient, limiting complications and morbidity, and for the surgeon, improving his comfort and reducing his mental workload. The major pitfall of the current technique is the loss of localisation reliability during the intervention due to the registration process and the presence of two screens (to locate the object on the endoscopic image and on the scan) We would like to propose solutions to these limitations using a device based on augmented reality and 3D reconstructions. It would guide the gesture in endonasal endoscopic surgery by displaying high-risk areas and surgical landmarks in a reliable and precise way.
详细描述
The available literature offers numerous expert and consensus opinions supporting the usefulness and acceptance of endonasal navigation and encouraging development of optimised navigation systems Augmented reality (AR) allows the surgeon to visualise the preoperative imaging information in the form of a projection that is displayed on the endoscopic image screen. This application, used in other surgical fields, is promising. The EnCoV team of the Institut Pascal laboratory has notably developed an innovative functional AR system, in laparoscopy in gynaecological, digestive and urological surgery The feasibility in endonasal surgery has been confirmed in a cadaveric model and its clinical utility shown on various systems. However, the question of accuracy during calibration and during the surgery remains.
We propose a surface registration system based on 3D reconstructions of patient's face and endoscopic images. It would match 3D reconstructions of the patient's images with 3D reconstructions of the CT scan or MRI images. Thus, this device would be able to provide a large number of reference points for precise mapping. Tissue recognition (texture, contours, etc.) processes would allow to display the right information in the right place.
To date, there is no such AR endonasal navigation system. Thus, the technical evolutions developed in laparoscopy by the EnCoV team would be transposed the ENT field in order to optimise endonasal endoscopy.
Outline of the study :
Feasibility study, observational, transversal. Feasibility criterion: To evaluate the feasibility of a device based on AR to guide the gesture in endonasal endoscopic surgery by displaying invisible high-risk areas and surgical landmarks in a reliable and accurate way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Admitted in the ENT and Cervico-Facial Surgery department of the Gabriel Montpied University Hospital in Clermont-Ferrand.
- •From November 2020 to October 2021,
- •Requiring endoscopic sinus surgery
- •With good quality imaging (CT scan and/or MRI)
排除标准
- •Patient under the age of 18
结局指标
主要结局
Target registration error
时间窗: day 1
The feasibility of integrating medical imaging data with endoscopic images will be assessed by the accuracy of the registration obtained, called TRE (Target Registration Error). This is a standard evaluation methodology of a registration between modalities.
次要结局
未报告次要终点