Dr. Norio Fukami and his team at the Mayo Clinic celebrate their first procedure with the ELS System. Source: EndoQuest
EndoQuest Robotics Inc. said a surgeon at the Mayo Clinic has successfully completed a robotic procedure as part of its Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine, or PARADIGM, Trial. The trial is a multicenter study intended to evaluate the company’s Endoluminal Surgical System for use in lower gastrointestinal track procedures.
Dr. Norio Fukami successfully completed an endoscopic submucosal dissection (ESD) using the Endoluminal Surgical (ELS) System to remove a complex colorectal lesion measuring 4 cm (1.5 in.) in size. He is a professor of medicine and director of Therapeutic Endoscopy and Interventional Gastrointestinal (GI) Endoscopy Fellowship at Mayo Clinic in Arizona. Fukami performed the ESD procedure as part of a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial.
“The device was instinctive and easy to use, enabling dynamic traction and counter-traction of surgical technique, and made a complex procedure that would traditionally be much more challenging feel relatively straightforward,” said Dr. Fukami.
“This technology represents a monumental shift in our ability to perform ESD and other advanced endoluminal therapies,” he added. “For the first time, we’re equipped with a true surgeon’s ‘second hand’ that makes these procedures more natural and reproducible, with the potential to significantly reduce patients’ and physicians’ burden.”
EndoQuest said that Fukami is a world-renowned expert in ESD and other endoluminal and pancreaticobiliary techniques. He was also an editor for the first English textbook on ESD.
EndoQuest said its PARADIGM surgical system offers flexibility, advanced instrumentation, and an ergonomic design. | Source: EndoQuest Robotics
EndoQuest hopes to help patients avoid invasive procedures
ESD has emerged as an effective treatment option for early lesions in the GI tract. It has enabled many patients to avoid invasive surgeries such as colectomies, said EndoQuest.
Despite these benefits, ESD and other advanced endoluminal therapies are technically challenging with steep learning curves, the Houston company acknowledged. This is due in large part to the inherent limitations of standard flexible endoscopes and instrumentation, it noted.
EndoQuest said it designed its system to make advanced endoluminal procedures easier to learn and perform. The ELS System enables surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy, the company asserted.
Pre-clinical data presented by Brigham and Women’s Hospital at Digestive Disease Week (DDW) in 2024 and 2025 demonstrated that the ELS System significantly reduces the learning curve compared to conventional techniques for ESD and full-thickness defect closure among novice gastroenterologists.
“Therapeutic endoscopy represents one of the fastest-growing areas within medicine,” stated Dr. Todd Wilson, chief medical officer and chairman of the International Advisory Board of EndoQuest Robotics. “With a greater than 50% increase in the number of advanced endoscopy fellowship programs over the past decade, there is clearly a growing interest in advancing endoluminal, organ-sparing care, and our technology is positioned to drive this therapeutic shift.”
PARADIGM Trial to continue across the U.S.
The PARADIGM Trial is enrolling 50 subjects across five leading U.S. healthcare institutions: Brigham and Women’s Hospital in Boston; Mayo Clinic in Scottsdale, Ariz.; Cleveland Clinic in Cleveland; AdventHealth in Orlando, Fla.; and HCA Healthcare in Houston. Following trial completion, EndoQuest Robotics plans to submit a De Novo request for authorization to market the ELS System in the U.S.
In July, EndoQuest closed a Series D-2 funding round. The company said the funding will fuel the advancement of its flexible endoluminal surgical platform, supporting the PARADIGM clinical trial.
EndoQuest said its ELS System is an investigational device, has not yet been fully cleared by the FDA, and is not yet available for commercial sale in the U.S.
Editor’s note: Iman Jeddi, senior vice president and general manager at Intuitive Surgical, will deliver a keynote at RoboBusiness 2025, which will be on Oct. 15 and 16 in Santa Clara, Calif. She will discuss the design and launch of the da Vinci 5 surgical robot.
RoboBusiness will be co-located with DeviceTalks West, the premier industry event for medical technology professionals. Register now to attend.
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