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EndoQuest Robotics Completes Enrollment in Pivotal Trial, Reports 100% En Bloc Resection Rate

EndoQuest Robotics finished enrolling 49 subjects in its pivotal PARADIGM trial for robotic colorectal lesion removal, citing a 100% en bloc resection rate.

Robotics & Automation Surgical Robotics
robotics medical devices FDA endoscopy surgical robotics
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Overview

EndoQuest Robotics has concluded subject enrollment in its pivotal PARADIGM trial, a multicenter investigational device exemption (IDE) study evaluating the company’s Endoluminal Surgical (ELS) System for robotic endoscopic submucosal dissection (ESD), according to Medical Device Network. The trial, whose full name is the Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine, involved 49 participants and a total of 50 robotic ESD procedures, according to Medical Device Network.

What We Know

  • The study enrolled across five U.S. healthcare centers: AdventHealth in Orlando, Baylor St. Luke’s in Houston, Cleveland Clinic in Cleveland, HCA Healthcare in Houston, and Mayo Clinic in Scottsdale, according to Medical Device Network.
  • Six investigators — three colorectal surgeons and three gastroenterologists — completed the procedures, according to Medical Device Network.
  • Preliminary trial data showed a 100% en bloc resection rate and a 100% conversion-free rate, according to Medical Device Network. The company also reported a 95.8% R0 resection rate and said no device-related bleeding or perforations had been observed at the time of reporting, according to Medical Device Network.
  • The trial is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures intended to remove lesions in the rectum and sigmoid colon, according to Medical Device Network.
  • John Magnasco, EndoQuest Robotics’ vice president of quality and regulatory, 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,” according to Medical Device Network.
  • EndoQuest 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,” according to Medical Device Network.
  • The company plans to include the trial results in a De Novo Classification Request seeking FDA authorization to market the ELS System in the United States, according to Medical Device Network.
  • EndoQuest first won an IDE from the FDA in December 2024, allowing it to begin the clinical trial, according to Medical Device Network. The FDA subsequently approved the trial’s final enrollment stage in January 2026 following a favorable interim safety review, according to a company announcement reproduced by The AI Journal.
  • The ELS System remains an investigational device that has not been cleared by the FDA and is not yet available for commercial sale in the United States, according to The AI Journal.

What We Don’t Know

  • The results described are preliminary; EndoQuest has not yet completed data verification or final statistical analysis, and the figures could change once that process concludes, according to Medical Device Network.
  • No timeline has been disclosed for when EndoQuest will file its De Novo Classification Request or when the FDA might rule on it.
  • Longer-term outcomes for the 49 enrolled subjects, including durability of resection and any delayed complications, have not yet been reported.

Analysis

The PARADIGM trial is a test case for whether robotic platforms can move endoluminal surgery — procedures performed through natural body orifices rather than external incisions — into a new category between conventional endoscopy and open surgical robotics. A 100% en bloc resection rate, if it holds after final statistical review, would represent a favorable outcome for a still-experimental device class, since en bloc removal (extracting a lesion in one piece rather than in fragments) is generally associated with more complete pathology assessment and lower recurrence risk in endoscopic resection procedures. The company’s own emphasis on “preliminary” results and the pending De Novo submission signals that regulatory clearance, not just trial completion, is the next real milestone to watch.