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Robotic Surgery Achieves Perfect Resection Rates
27 Jul
Summary
- Robotic endoscopic submucosal dissection trial concluded with 49 participants.
- Trial reported 100% en bloc resection and 100% conversion-free rates.
- No device-related bleeding or perforations were observed in the study.
EndoQuest Robotics announced the conclusion of subject enrollment for its PARADIGM trial, which assessed the Endoluminal Surgical (ELS) system. This multicentre investigational device exemption study enrolled 49 participants across five US healthcare facilities.
The trial involved 50 robotic endoscopic submucosal dissection (ESD) procedures performed by six investigators. Preliminary data indicated a perfect 100% en bloc resection rate and a 100% conversion-free rate. The R0 resection rate stood at 95.8%, with no reported device-related bleeding or perforations.
"Having been involved in the surgical robotics space for over 25 years, I have never seen clinical trial results this good," stated John Magnasco, EndoQuest Robotics' vice-president of quality and regulatory. The company plans to use these results for a De Novo Classification Request to market the ELS system in the US.
The ELS system is designed for robotic ESD procedures to remove lesions in the rectum and sigmoid colon. CEO Eduardo Fonseca expressed confidence in the platform's potential to improve patient outcomes and provide significant clinical value.
