EndoQuest Robotics, a developer of endoluminal robotic surgical technology, says it has completed the first procedures of its pivotal clinical trial, Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine (PARADIGM) (Clinicaltrials.gov).
Using EndoQuest’s Endoluminal Surgical (ELS) System, two colorectal endoscopic submucosal dissection (ESD) procedures were completed by Dr Eric Haas, Chief of Colorectal Surgery at HCA Houston Healthcare Medical Center where the procedures were performed.
Dr Haas is also the Chief of Colorectal Surgery at Houston Methodist Hospital, the Program Director for Minimally Invasive Colorectal Surgery at the University of Texas at Houston, and a world-renowned pioneer in robotic colorectal surgery.
“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.”
The first two robotic ESD procedures were performed on complex lesions located in the rectum and sigmoid colon, including one fibrotic lesion measuring over 5 cm.
This investigational device exemption (IDE) approved study is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures for the removal of colorectal lesions.
Fifty subjects will participate across five leading United States healthcare institutions, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston).
Following completion of the PARADIGM trial, EndoQuest Robotics plans to submit a De Novo request for authorization to market the ELS System in the United States.
“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.”
“The data is clear that ESD is the ideal technique for removal of early colorectal lesions, yet ESD has not been widely adopted in the US, generally due to its steep technical difficulty and learning curve,” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics.
“Our endoluminal robotic system is designed to solve these challenges, which should ultimately allow a greater number of physicians to adopt this minimally invasive technique and resultingly, replace a significant number of more invasive procedures, such as colectomies.”
The ELS System is designed to enable endoluminal procedures with the visualization, precision, and main tenets of conventional surgical technique, allowing for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy.
The ELS System combines the flexibility of endoscopy that can navigate the curvature of gastrointestinal (GI) anatomy with the conventional surgical technique and precision enabled by a robotic surgical system.
The result is the capability to perform complex surgery in locations not previously possible via natural orifice access, avoiding external incisions and bringing the physician directly to the target of disease.
