Minimally invasive surgery just took a major step forward — thanks to robots! EndoQuest Robotics has officially launched its pivotal PARADIGM clinical trial, completing the first two endoscopic submucosal dissection (ESD) procedures using its investigational Endoluminal Surgical (ELS) System. The milestone procedures were performed at HCA Houston Healthcare Medical Center by Dr. Eric Haas, a global leader in robotic colorectal surgery.
The trial, formally known as Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine, marks a turning point in robotic-assisted GI surgery. ESD is a highly effective method for removing early-stage colorectal lesions, but it remains underused in the U.S. due to its technical complexity. EndoQuest’s ELS System is designed to change that, offering robotic precision without external incisions.
The first cases involved difficult lesions in the rectum and sigmoid colon, including one fibrotic lesion over 5 cm in size. Using natural orifice access, the robotic platform allowed direct, precise dissection of complex tissue — a task that traditionally requires open or laparoscopic surgery.
What makes the ELS System different is its hybrid approach. It blends the flexibility of endoscopy with the control and dexterity of conventional surgery. This allows the surgeon to operate from within, using robotic instruments to reach and remove diseased tissue in areas previously considered inaccessible through non-invasive methods.
The PARADIGM trial will enroll 50 patients across five leading U.S. institutions: Brigham and Women’s Hospital, Mayo Clinic, Cleveland Clinic, AdventHealth, and HCA Healthcare. Following completion, EndoQuest plans to submit a De Novo request to bring the ELS System to market in the U.S.
EndoQuest Robotics’ aim is clear — reduce the need for invasive colectomies by making ESD more accessible to physicians across the country. If successful, the system could enable a significant shift in colorectal treatment, improving outcomes while reducing recovery time, complications, and healthcare costs.
“I am honored to have performed the first procedures in this important clinical study,” said Dr. Eric Haas, Chief of Colorectal Surgery at HCA Houston Healthcare Medical Center. “This novel robotic system has the potential to truly advance how we treat patients with colorectal disease, and we are eager to continue advancing this study and gathering data on its use in the clinical setting.”
