PARADIGM (prospective assessment of a robotic-assisted device in gastrointestinal medicine) evaluates the company’s Endoluminal Surgical (ELS) system. Using the system, Dr. Eric Haas completed two colorectal endoscopic submucosal dissection (ESD) procedures in Houston.
The two procedures targeted complex lesions located on the rectum and sigmoid colon, including one fibrotic lesion measuring over 5 cm.
“I am honored to have performed the first procedures in this important clinical study,” said Dr. Haas. “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.”
For more on the wide world of surgical robotics, see our special report on the space.
The procedures took place as part of EndoQuest Robotics’ FDA investigational device exemption (IDE) study approved last December. It evaluates the ELS System in robotic ESD procedures for the removal of colorectal lesions. Investigators plan to enroll 50 subjects across five leading U.S. healthcare institutions.
Upon the trial’s completion, EndoQuest Robotics plans to submit an FDA de novo request for the ELS System.
“We are grateful to Dr. Haas and the team at HCA Houston Healthcare for leading off this pivotal IDE Study,” said Eduardo Fonseca, Interim CEO of EndoQuest Robotics. “Our goal is to revolutionize surgery through enabling less invasive, more effective approaches, and these first procedures mark a significant milestone towards achieving that goal.”
More about the EndoQuest Robotics ELS System
EndoQuest designed its surgical robot platform to address unmet needs in gastrointestinal and other endoluminal surgeries. It developed a system that offers precision and flexibility to improve patient outcomes. The company says it enables endoluminal procedures with the visualization, precision and main tenets of conventional surgical techniques. It allows for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy.
The proprietary technology navigates and performs procedures within the body’s lumina spaces, allowing for minimally invasive interventions.
EndoQuest Robotics’ ELS System combines the flexibility of endoscopy with the conventional surgical technique and precision enabled by robotics. It allows for complex surgeries in locations not previously possible through natural orifice access. The system avoids external incisions and brings the physician directly to the target of the disease.
The platform makes it possible for therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach. EndoQuest raised $42 million to support the platform a year ago.
