EndoQuest Robotics has received FDA approval to proceed with the final enrollment phase of its pivotal Paradigm trial evaluating a robotic endoluminal system for gastrointestinal procedures.
The multicenter trial is assessing the safety and efficacy of EndoQuest’s Endoluminal Surgical System for robotic-assisted endoscopic submucosal dissection in the rectum and sigmoid colon, according to a Jan. 15 news release.
The first procedures in the trial were completed by physicians at major health systems, including gastroenterologist Norio Fukami, MD, of Mayo Clinic in Arizona in Phoenix, who became the first to perform a fully robotic ESD procedure as part of an investigational device exemption trial. Colorectal surgeons Matthew Albert, MD, of AdventHealth Orlando and Eric Haas, MD, of HCA Houston Healthcare also participated.
The trial is enrolling 50 patients across five U.S. sites: Houston-based HCA Healthcare, Mayo Clinic in Scottsdale, Cleveland Clinic, Boston-based Brigham and Women’s Hospital Boston and AdventHealth Orlando.
