EndoQuest’s multicenter PARADIGM trial has moved beyond its first site, with AdventHealth Orlando completing its first colorectal endoscopic submucosal dissection using the company’s Endoluminal Surgical System. The IDE-approved study plans to enroll 50 subjects across five U.S. centers and is designed to evaluate the safety and effectiveness of robotic ESD for colorectal lesion removal.
The core development is operational: PARADIGM is now functioning as a true multicenter pivotal, not a single-site proof of concept. In addition to AdventHealth, participating institutions include HCA Houston Healthcare Medical Center, Brigham and Women’s Hospital, Mayo Clinic in Scottsdale, and Cleveland Clinic. Upon completion, EndoQuest intends to file a De Novo request to market the platform in the U.S., positioning the system within a first-of-a-kind regulatory pathway rather than a 510(k) predicate comparison.
Strategically, EndoQuest is attempting to industrialize a procedure that has struggled to gain broad adoption in the U.S. due to its steep learning curve and perforation risk. Suppose a flexible robotic platform can standardize traction, triangulation, and access in the colon. In that case, the company can plausibly shift a subset of complex polypectomy and early neoplasia out of the OR and away from segmental resections. The De Novo plan signals a bid to define the category and its performance benchmarks. At the same time, the site mix—academic flagships plus large health systems—builds a bench of operators who can shape training and credentialing norms. This is a defensive and expansion play at once: defensive against conventional ESD tool makers and transabdominal robotics, and expansion into an underpenetrated U.S. ESD market with a device-centric workflow.
For sites, the move tests whether endoscopy suites can absorb a robotic platform without disrupting throughput. Capital budgeting, service contracts, and room configuration will be immediate hurdles, as will privileging—whether gastroenterology or colorectal surgery owns the program has downstream implications for staffing, anesthesia coverage, and referral capture. Training and proctoring logistics will determine how quickly centers progress up the learning curve; a multicenter pivotal study offers a live read on reproducibility across different operator backgrounds. Sponsors and CROs watching device trials should note the operational choreography: standardized lesion classification, consistency in specimen handling, and independent assessment of outcomes will be necessary to harmonize data. Regulators will inevitably focus on safety signals, such as perforation and bleeding, as well as technical success proxies, including en bloc and margin-negative resection, and the need for retreatment. They may also probe generalizability beyond high-volume centers.
The commercial path is not just regulatory. Reimbursement for ESD is evolving but uneven, and hospitals will need a clear case that robotic ESD expands indications, reduces the need for conversions to surgery, shortens the length of stay, or consolidates complex resections into fewer sessions. Competing technologies range from advanced endoscopic knives and traction systems to transanal platforms used by colorectal surgeons. EndoQuest must demonstrate that robotics materially improves consistency and team efficiency, rather than adding setup time. Watch for the cadence of additional site activations, early aggregated performance metrics such as procedure time and adverse events, and evidence that outcomes hold across institutions rather than clustering with a single expert operator. If PARADIGM produces a stable safety profile with convincing technical success rates, a De Novo clearance could follow; however, scaling adoption will hinge on training infrastructure, service reliability, and a capital model that aligns with endoscopy economics. Expansion into upper GI indications would be the logical next test of platform breadth, but the first proof remains whether robotic ESD can move from showcase cases to routine practice.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
