EndoQuest Advances Multicenter PARADIGM Trial with Completion of Procedures at Baylor St. Luke’s Medical Center

Clinical progress expands to Baylor St. Luke’s with robotic endoscopic submucosal dissection procedures performed by Dr. Mohamed Othman and Dr. Tara Keihanian

HOUSTON--(BUSINESS WIRE)--EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, today announced that Baylor St. Luke’s Medical Center has been activated as a trial site and has successfully completed its first procedures in the PARADIGM Trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine), a pivotal multicenter clinical study (Clinicaltrials.gov).

The robotic ESD procedures were completed using EndoQuest’s Endoluminal Surgical (ELS) System by Dr. Mohamed Othman, Professor of Medicine and Section Chief of Gastroenterology and Hepatology at Baylor College of Medicine, and Dr. Tara Keihanian, Assistant Professor of Medicine and interventional gastroenterologist at Baylor College of Medicine.

“Using the ELS System to perform this ESD offered a glimpse into the future of true endoluminal surgery,” said Dr. Othman. “With continued experience and following regulatory clearance, I expect robotics to become a primary modality in my practice, reshaping how I approach these procedures for appropriately selected patients.”

“Robotics represents a significant advancement in the evolution of endoluminal procedures,” said Dr. Keihanian. “We are proud to contribute to this important work and to help build the clinical evidence that will inform the future of the field.”

The PARADIGM Trial is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures for the removal of lesions in the rectum and sigmoid colon. The study is enrolling 50 subjects across five leading U.S. healthcare institutions: HCA Healthcare (Houston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and Baylor St. Luke’s (Houston). Following completion of the PARADIGM Trial, EndoQuest Robotics plans to submit a De Novo Classification Request for authorization to market the ELS System in the U.S.

“It is a privilege to collaborate with Dr. Othman and Dr. Keihanian, whose commitment to driving endoscopic innovation aligns perfectly with the goals of the PARADIGM Trial,” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics. “The addition of Baylor strengthens the program and builds on the positive progress we have seen across all participating sites. We look forward to continuing to learn from their experience as we advance this groundbreaking technology.”

“These first cases at Baylor further highlight the potential of our platform to deliver meaningful value in the endoscopy suite,” said Eduardo Fonseca, CEO of EndoQuest Robotics. “The completion of two consecutive procedures by two different gastroenterologists is an encouraging milestone within the PARADIGM Trial and further contributes to the real-world clinical experience being developed across the study.”

About EndoQuest Robotics

EndoQuest Robotics is redefining what is possible in endoluminal procedures through flexible robotic technologies. The company’s platform is designed to bring true surgical capabilities to endoluminal intervention — enabling greater precision, dexterity, and control to simplify complex procedures and expand therapeutic possibilities in less invasive care. EndoQuest’s Endoluminal Surgical System is currently being evaluated in clinical studies, including the PARADIGM Trial. For more information, visit www.endoquestrobotics.com.

EndoQuest’s Endoluminal Surgical System is an investigational device, has not been cleared by the FDA, and is not yet available for commercial sale in the United States.