Endoquest Robotic System Gets FDA "OK" to Launch Clinical Trial

Endoquest Robotics has received FDA approval for an investigational device exemption (IDE) to begin a pivotal clinical trial of its robotic system for colorectal surgery. The trial, named the Paradigm study, will evaluate the safety and effectiveness of Endoquest's robotic endoscopic platform in removing colorectal lesions. Slated to launch in early 2025, the trial will take place at five prominent U.S. hospitals, including Brigham and Women’s Hospital, Mayo Clinic, and Cleveland Clinic, enrolling 50 patients. This cutting-edge technology aims to redefine minimally invasive colorectal procedures by navigating the body through natural orifices, reducing tissue trauma, scarring, and the need for more invasive surgeries like colectomies.

Endoquest’s robotic system represents a leap forward in endoluminal surgery, offering improved patient outcomes and shorter recovery times. Previously, the system was accepted into the FDA’s Safer Technologies Program, fast-tracking its development for public use. A preclinical study demonstrated its potential advantages, including superior procedure outcomes, a reduced learning curve, and faster operation times compared to conventional techniques. The privately held company, headquartered in Houston, secured $42 million in funding last year to further advance its innovative surgical platform.