EndoQuest Robotics has finished enrolment in the PARADIGM IDE trial of its Endoluminal Surgical (ELS) robotic system, enrolling 49 participants and performing 50 robotic ESD procedures across five U.S. centres. Preliminary results report a 100% en bloc resection rate, 100% conversion-free rate and a 95.8% R0 resection rate, with no device-related bleeding or perforations observed. The company will include these data in a De Novo submission to the FDA and continues active clinical follow-up.
EndoQuest Completes PARADIGM Enrollment as ELS Robotic System Shows Promising Early Results
The trial has been designed to evaluate the system for robotic ESD procedures to remove lesions in the rectum. Credit: Anatomy Image / Shutterstock.com.
EndoQuest Robotics has completed enrolment in the multicentre Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine (PARADIGM) investigational device exemption (IDE) trial, evaluating its Endoluminal Surgical (ELS) robotic platform for endoscopic submucosal dissection (ESD).
Study Overview
The IDE study enrolled 49 participants across five U.S. centres — AdventHealth (Orlando), Baylor St. Luke's (Houston), Cleveland Clinic (Cleveland), HCA Healthcare (Houston) and Mayo Clinic (Scottsdale) — and included a total of 50 robotic ESD procedures. Six investigators (three colorectal surgeons and three gastroenterologists) carried out the procedures.
Preliminary Results
Company-reported, preliminary outcomes from the PARADIGM trial include:
- 100% en bloc resection rate
- 100% conversion-free rate
- 95.8% R0 resection rate (microscopically margin-negative)
- No device-related bleeding or perforations observed at the time of reporting
John Magnasco, Vice-President of Quality and Regulatory at EndoQuest, 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."
Eduardo Fonseca, CEO of EndoQuest Robotics, added: "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."
The PARADIGM study was designed to assess the safety and effectiveness of the ELS system for robotic ESD procedures to remove lesions in the rectum and sigmoid colon. The device remains under active clinical follow-up as part of this pivotal trial.
EndoQuest plans to include PARADIGM data in a De Novo Classification Request to the U.S. Food and Drug Administration to seek marketing authorization for the ELS system. The company received IDE clearance from the FDA in December 2024 to commence this clinical evaluation.
What Is ESD? Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique used to remove larger or more complex gastrointestinal lesions in a single piece (en bloc), improving pathological assessment and reducing recurrence risk.
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