EndoQuest Advances Multicenter PARADIGM Trial
EndoQuest Robotics, Inc. has announced that AdventHealth Orlando has successfully completed its first procedure in the PARADIGM Trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine), a pivotal multicenter clinical study (Clinicaltrials.gov). AdventHealth Orlando is the second clinical site to complete a procedure in the trial, following HCA Houston Healthcare Medical Center, which was also recently announced.
A colorectal endoscopic submucosal dissection (ESD) was performed using the Endoluminal Surgical (ELS) System by Dr. Matthew Albert, a colorectal surgeon at AdventHealth Orlando and inventor of the revolutionary surgical technique known as TAMIS (Transanal Minimally Invasive Surgery).
“At AdventHealth, we’re always looking for ways to leverage technology to help our patients feel whole,” Albert said. “One way to do that is by revolutionizing techniques for less invasive treatments that lead to a smoother recovery for our patients. This technology will allow us to reach deeper into the digestive system, which means we can often treat the problem without removing healthy tissue.”
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’re in great hands with Dr. Albert for this trial”, said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics. “It’s a privilege to see a recognized pioneer in minimally invasive colorectal surgery apply the ELS System in the clinical setting, and we’re looking forward to seeing the impact of his work in this study.”
“By expanding our trial to multiple centers, we are accelerating the path towards making incisionless robotic surgery a reality for patients,” said Eduardo Fonseca, CEO of EndoQuest Robotics. “Our focus is not only on clinical excellence, but also on ensuring this platform is scalable, accessible, and positioned for broad adoption and lasting value once it reaches the market.”
Source: EndoQuest Robotics, Inc.