PARADIGM Trial enrollment concludes following the successful completion of fifty robotic endoscopic submucosal dissection procedures by six different investigators
Preliminary trial results presented at the 2026 Society of Robotic Surgery Annual Meeting
HOUSTON–(BUSINESS WIRE)–EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, today announced that enrollment in its pivotal multicenter investigational device exemption (IDE) clinical study, the PARADIGM Trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine), has concluded after the completion of 50 robotic endoscopic submucosal dissection (ESD) procedures across 49 subjects (Clinicaltrials.gov). Preliminary results for the trial were presented at the 2026 Society of Robotic Surgery (SRS) Annual Meeting.
The robotic ESD procedures were completed using EndoQuest’s Endoluminal Surgical (ELS) System by 6 different investigators across 5 institutions, including 3 colorectal surgeons and 3 gastroenterologists. Preliminary results indicate a 100% en bloc resection rate, 100% conversion-free rate, 95.8% R0 resection rate, and no device-related bleeding or perforations reported to date.*
“Having been involved in the surgical robotics space for over 25 years, I have never seen clinical trial results this good,” said John Magnasco, VP of Quality and Regulatory at EndoQuest Robotics. “We look forward to completing data verification and final statistical analyses as we prepare for our De Novo submission.”
“It has been incredibly rewarding to witness the progress of this study from beginning to end,” said Dr. Eric Haas, Chief of Colorectal Surgery at HCA Houston Healthcare and Houston Methodist Hospital. “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.”
The PARADIGM Trial is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures for the removal of lesions in the rectum and sigmoid colon. The study enrolled at five leading U.S. healthcare institutions: HCA Healthcare (Houston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and Baylor St. Luke’s (Houston). EndoQuest Robotics will include the PARADIGM Trial results as part of a De Novo Classification Request for authorization to market the ELS System in the U.S.
“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,” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics. “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.”
“For a new robotic platform to succeed, it must provide meaningful clinical and commercial value,” said Eduardo Fonseca, CEO of EndoQuest Robotics. “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.”
*Results are preliminary and reflect clinical data available as of July 18, 2026; data remain subject to ongoing follow-up, verification, and database review.
About EndoQuest Robotics
EndoQuest Robotics is redefining what is possible in endoluminal procedures through flexible robotic technologies. The company’s platform is designed to bring true surgical capabilities to endoluminal intervention — enabling greater precision, dexterity, and control to simplify complex procedures and expand therapeutic possibilities in less invasive care. The EndoQuest Endoluminal Surgical System is currently being evaluated in the pivotal multicenter PARADIGM Trial, which has completed enrollment and remains in active clinical follow-up. For more information, visit www.endoquestrobotics.com.
EndoQuest’s Endoluminal Surgical System is an investigational device, has not been cleared by the FDA, and is not yet available for commercial sale in the United States.
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