Evaluation of current and emerging endoluminal robotic platforms using the IDEAL framework

摘要

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: 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.