EndoQuest Robotics, a privately held medical device company and pioneer in the development of flexible endoluminal robotic technologies, has submitted an Investigational Device Exemption (IDE) application for its pivotal colorectal clinical study.
EndoQuest says its mission is to “transform surgical outcomes for minimally invasive surgery” (MIS) with its groundbreaking flexible robotic system.
This IDE will enable EndoQuest to begin their Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study, which is a prospective, multi-center, open-label study.
With an expected enrollment of 50 subjects, the PARADIGM study will be conducted at five leading US healthcare facilities, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston).
As part of the PARADIGM study, globally recognized gastroenterologists and colorectal surgeons will perform robotic endoscopic submucosal dissection (ESD) procedures for removal of colorectal lesions using the EndoQuest Robotics Endoluminal Surgical (ELS) System.
Results from a pre-clinical ESD study presented earlier this year at Digestive Disease Week (DDW2024) demonstrated that the ELS System had superior procedural outcomes, a shorter learning curve, and reduced procedure time versus the conventional technique.
The IDE submission is subject to review by the US Food and Drug Administration (FDA) and must be approved prior to initiating this study.
The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors, including the extent of potential comments, questions, and any additional information requested by the FDA.
Eduardo Fonseca, interim CEO of EndoQuest Robotics, says: “Once approved, our IDE enables the ELS System to ship to clinical sites and be studied for safety and efficacy.
“While not yet commercialized, it is a critical step forward and drives value in the company as the future benchmark for ESD and other minimally invasive procedures.”
Dr Todd Wilson, chief medical officer and chairman of the scientific advisory board of EndoQuest Robotics, says: “There is a significant unmet need for improved treatment of colorectal disease in the US.
“The robotic ESD procedure provides the opportunity to clearly demonstrate the potential benefits of our flexible robotic system in terms of outcomes, complications, healthcare costs, and much more, and should ultimately pave the way for the system to revolutionize a wide and growing range of other procedures across the globe.”
