HOUSTON, Texas — EndoQuest Robotics said the U.S. Food and Drug Administration has approved the company to initiate the final stage of its pivotal PARADIGM Trial, clearing the way for completion of enrollment following a favorable interim safety review.
The PARADIGM Trial, or Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine, is an Investigational Device Exemption study evaluating EndoQuest’s Endoluminal Surgical System for use in endoscopic submucosal dissection procedures. The FDA’s decision followed the agency’s review of safety data from the first group of patients treated in the study.
The approval allows EndoQuest to complete enrollment ahead of its planned De Novo Classification Request to seek authorization to market the Endoluminal Surgical System in the United States.
The initial procedures in the trial were performed by physicians recognized as pioneers in endoluminal surgery, including gastroenterologist Dr. Norio Fukami of Mayo Clinic Arizona, who became the first gastroenterologist worldwide to perform a fully robotic endoscopic submucosal dissection as part of an IDE trial. Additional procedures were completed by colorectal surgeons Dr. Matthew Albert of AdventHealth Orlando and Dr. Eric Haas of HCA Houston Healthcare.
“Using the ELS System, I have been able to complete dissections and closures with surgical precision in anatomy that is typically challenging or impossible to address using standard transanal techniques,” said Dr. Haas, Chief of Colorectal Surgery at HCA Houston Healthcare and Houston Methodist Hospital, and lead enroller during the first stage of the PARADIGM Trial. “The platform feels like a natural extension of my robotics skillset as a colorectal surgeon, and I look forward to continuing this trial as we explore how it may expand what’s possible in minimally invasive colorectal procedures.”
John Magnasco, Vice President of Quality and Regulatory at EndoQuest Robotics, said the company’s engagement with the FDA has been constructive throughout the process.
“We continue to be pleased with our clear, timely and positive interactions with the FDA via their Safer Technologies Program,” Magnasco said. “This approval reflects a collaborative approach that prioritizes patient safety and innovation. We look forward to working closely with the Agency as we move toward De Novo submission.”
The PARADIGM Trial is designed to assess the safety and effectiveness of the Endoluminal Surgical System in robotic endoscopic submucosal dissection procedures for the removal of lesions in the rectum and sigmoid colon. The study is enrolling 50 patients across five U.S. healthcare institutions: HCA Healthcare in Houston, Mayo Clinic in Scottsdale, Cleveland Clinic in Cleveland, Brigham and Women’s Hospital in Boston, and AdventHealth in Orlando.
Eduardo Fonseca, Chief Executive Officer of EndoQuest Robotics, said the milestone advances the company’s broader strategy in endoscopic robotics.
“With every case, we advance toward defining a new category of surgery and further build on our leading position to establish robotics in the endoscopic suite,” Fonseca said. “This milestone brings us closer to delivering meaningful value for patients, physicians, and healthcare systems.”
Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics, said the interim results support the company’s long-term goals.
“We are highly encouraged by the positive results of the first stage of our trial and the dedication of our investigators,” Wilson said. “Our mission is to redefine what’s possible in minimally invasive procedures and enable the next shift in patient outcomes. This approval to complete enrollment in our pivotal trial is a testament to the progress we have made towards achieving that goal.”
