Houston-based EndoQuest’s PARADIGM trial concluded after the completion of 50 robotic endoscopic submucosal dissection (ESD) procedures across 49 subjects. The company presented outcomes at the 2026 Society of Robotic Surgery (SRS) Annual Meeting.
The FDA granted investigational device exemption (IDE) for the study in December 2024. In May 2025, the company announced the first colorectal cases in the trial. In October 2025, the company reported the completion of the world’s first fully robotic endoscopic submucosal dissection (ESD) performed by a gastroenterologist in an IDE trial.
Six investigators across five institutions involved in the study included three colorectal surgeons and three gastroenterologists. Preliminary results indicated 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.
EndoQuest designed its surgical robot platform to address unmet needs in GI and other endoluminal surgeries. The system can deliver precision and flexibility to improve patient outcomes. The company says it enables endoluminal procedures with the visualization, precision and main tenets of conventional surgical techniques. It allows for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy.
The company set up its PARADIGM trial to evaluate the safety and effectiveness of its ELS system in robotic ESD procedures for the removal of lesions in the rectum and sigmoid colon. The company plans to include results in its submission for FDA de novo authorization to bring the ELS system to the U.S.
Commentary from EndoQuest officials and investigators
John Magnasco, VP of Quality and Regulatory at EndoQuest Robotics, said:
“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 at HCA Houston Healthcare and Houston Methodist Hospital, said:
“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 chair of the international advisory board of EndoQuest, said:
“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 of Endoquest, said:
“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.”
