Diya Shah, Freweini Martha Tesfai, Matthew Boal, Alberto Arezzo, Nader Francis
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引用次数: 0
摘要
背景:机器人辅助腔内系统在微创外科领域发展迅速。IDEAL框架(Idea, Development, Exploration, Assessment, and Surveillance)可用于评估新技术。本文综述了使用IDEAL框架的现有和新出现的腔内系统。方法:进行范围审查,包括所有现有的和正在开发的机器人辅助腔内系统。数据通过虚拟访谈、问卷调查、生物医学数据库、公司网站和同行评议文章收集。报告了关键指标,使每个系统能够分配到理想阶段。结果:审查确定了来自16家公司的17种不同的系统。9个系统在各自国家获得了监管部门的批准。我们的评估显示两个系统处于pre-IDEAL阶段0。七个系统处于构思阶段(第一阶段),六个系统处于发展阶段(第二阶段),两个系统完成了第三阶段。结论:机器人辅助腔内系统的长期临床数据存在空白,这表明在第4期没有系统。医学界、监管机构和行业专家之间的合作努力对于确保机器人学科的循证医学的交付至关重要。
Evaluation of current and emerging endoluminal robotic platforms using the IDEAL framework.
Background: Robotic-assisted endoluminal systems are rapidly evolving within the field of minimally invasive surgery. The IDEAL framework (Idea, Development, Exploration, Assessment, and Surveillance) can be used to evaluate novel technologies. This review provides a summary of current and emerging endoluminal systems using the IDEAL framework.
Methods: A scoping review was conducted to include all existing and developing robotic-assisted endoluminal systems. Data was collected via virtual interviews, questionnaires, biomedical databases, company websites, and peer-reviewed articles. Key metrics were reported, enabling the assignment of each system to an IDEAL stage.
Results: The review identified 17 distinct systems from 16 companies. Nine systems received regulatory approval in their respective countries. Our evaluation showed that two systems were at the pre-IDEAL Stage 0. Seven systems were in the Idea stage (Stage 1), six systems were in the Development stage (Stage 2) and two systems completed Stage 3. No system underwent long-term study evaluation (Stage 4).
Conclusions: There is a gap in long-term clinical data of robotic-assisted endoluminal systems, indicated by the absence of systems at Stage 4. Collaborative efforts amongst the medical community, regulatory bodies, and industry specialists are vital to ensure the delivery of evidence-based medicine in the discipline of robotics.
期刊介绍:
Minimally Invasive Therapy and Allied Technologies (MITAT) is an international forum for endoscopic surgeons, interventional radiologists and industrial instrument manufacturers. It is the official journal of the Society for Medical Innovation and Technology (SMIT) whose membership includes representatives from a broad spectrum of medical specialities, instrument manufacturing and research. The journal brings the latest developments and innovations in minimally invasive therapy to its readers. What makes Minimally Invasive Therapy and Allied Technologies unique is that we publish one or two special issues each year, which are devoted to a specific theme. Key topics covered by the journal include: interventional radiology, endoscopic surgery, imaging technology, manipulators and robotics for surgery and education and training for MIS.