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

Area of Science:

• Minimally Invasive Surgery
• Surgical Robotics
• Medical Device Evaluation

Background:

• Robotic-assisted endoluminal systems represent a rapidly advancing area in minimally invasive surgery.
• The IDEAL framework (Idea, Development, Exploration, Assessment, and Surveillance) provides a structured approach for evaluating novel surgical technologies.
• This review synthesizes the current landscape of these systems through the lens of the IDEAL framework.

Purpose of the Study:

• To comprehensively review and categorize existing and emerging robotic-assisted endoluminal systems.
• To assess the developmental stage of these systems using the IDEAL framework.
• To identify gaps in the evaluation and clinical data of these innovative surgical tools.

Main Methods:

• A scoping review methodology was employed to identify relevant systems.
• Data collection involved virtual interviews, questionnaires, database searches, company websites, and peer-reviewed literature.
• Systems were assigned to specific IDEAL framework stages based on collected metrics.

Main Results:

• Seventeen distinct robotic-assisted endoluminal systems from 16 companies were identified.
• Nine systems have obtained regulatory approval.
• The majority of systems are in early IDEAL stages (Stage 0, 1, and 2), with only two systems reaching Stage 3 and none progressing to Stage 4 (long-term assessment).

Conclusions:

• A significant gap exists in long-term clinical data for robotic-assisted endoluminal systems, evidenced by the lack of systems in IDEAL Stage 4.
• Enhanced collaboration between the medical community, regulatory bodies, and industry is crucial.
• This collaboration is essential for advancing evidence-based medicine in surgical robotics and ensuring patient safety and efficacy.