EndoQuest Robotics Finishes Enrollment in Surgical Robot Study

EndoQuest Robotics has completed enrollment in the PARADIGM pivotal IDE trial evaluating its Endoluminal Surgical (ELS) System for robotic endoscopic submucosal dissection (ESD).

The multicenter study has so far included 50 procedures across 49 subjects at five institutions, performed by six investigators. Preliminary results showed a 100% en bloc resection rate, 95.8% R0 resection rate, no device-related bleeding or perforations, and no conversions to alternative approaches.

The PARADIGM trial is evaluating the safety and effectiveness of the ELS (endoluminal surgical) system for robotic ESD procedures to remove rectal and sigmoid colon lesions. Conducted at five U.S. healthcare institutions, the trial results aim to support EndoQuest’s De Novo Classification Request for U.S. market authorization.

Comments from EndoQuest and clincians

John Magnasco, VP of quality and regulatory, EndoQuest: “Having been involved in the surgical robotics space for over 25 years, I have never seen clinical trial results this good. We look forward to completing data verification and final statistical analyses as we prepare for our De Novo submission.”

Dr. Eric Haas, chief of colorectal surgery, HCA Houston Healthcare and Houston Methodist Hospital: “It has been incredibly rewarding to witness the progress of this study from beginning to end. The EndoQuest platform has demonstrated its potential to bridge the gap between complex endoluminal intervention and true surgical capabilities, which I’m convinced will expand and improve the options we’re able to offer our patients.”

Dr. Todd Wilson, chief medical officer and international advisory board chair, EndoQuest: “We are extremely encouraged by these excellent preliminary results, particularly when viewed in the context of published en bloc and R0 resection rates reported with conventional ESD, especially during the early stages of physician adoption. Achieving these outcomes across six investigators representing different specialties and varying levels of experience with robotic and endoluminal procedures speaks to both the capabilities of the platform and the dedication of the investigators and clinical teams who participated in the PARADIGM Trial. We are deeply grateful for their partnership and shared dedication to improving patient care.”

Eduardo Fonseca, CEO, EndoQuest: “For a new robotic platform to succeed, it must provide meaningful clinical and commercial value. These preliminary results underscore the potential of robotic endoluminal surgery and strengthen our confidence in the value of the EndoQuest platform. PARADIGM marks a major milestone as we prepare for regulatory submission and advance our mission to improve patient outcomes through robotics-enabled care.”