EndoQuest Robotics has concluded subject enrolment in the Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine (PARADIGM) trial, assessing the Endoluminal Surgical (ELS) system.
The multicentre investigational device exemption (IDE) study involved 49 participants and included a total of 50 robotic endoscopic submucosal dissection (ESD) procedures.
It enrolled across five healthcare centres in the US: AdventHealth in Orlando, Baylor St. Luke’s in Houston, Cleveland Clinic in Cleveland, HCA Healthcare in Houston and Mayo Clinic in Scottsdale.
Six investigators, comprising three colorectal surgeons and three gastroenterologists, completed the procedures.
Preliminary trial data showed a 100% en bloc resection rate and a 100% conversion-free rate.
The company further stated that the R0 resection rate was 95.8% and noted that no device-related bleeding or perforations had been observed at the time of reporting.
EndoQuest Robotics quality and regulatory vice-president John Magnasco 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.”
The PARADIGM trial has been designed to evaluate the effectiveness and safety of the ELS system for robotic ESD procedures intended to remove lesions in the rectum and sigmoid colon.
The company will include the trial results as part of its De Novo Classification Request seeking authorisation to market the ELS system in the US.
EndoQuest Robotics CEO Eduardo Fonseca 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.”
EndoQuest Robotics’ ELS system remains under active clinical follow-up as part of this pivotal trial.
In December 2024, EndoQuest Robotics won an IDE from the US Food and Drug Administration, allowing the company to commence a clinical trial evaluating its surgical robotic system.
