The EASE study evaluates the safety and efficacy of the EndoZip system for endoscopic sleeve gastroplasty, a minimally invasive treatment for obesity. By introducing automated gastric remodeling, the technology aims to simplify complex manual suturing and standardize the procedure for single-operator workflows. The hospital, which already offers commercial EndoZip procedures, now joins the broader clinical effort to position endobariatric care between pharmacotherapy and traditional surgery.
Nitinotes Expands EASE Clinical Trial to Rome’s Gemelli Hospital
Prof. Ivo Boskoski has completed the inaugural EASE clinical trial procedures at Rome’s Fondazione Policlinico Universitario Agostino Gemelli IRCCS using the EndoZip Automated Suturing System. This expansion marks a pivotal step in gathering evidence for the device’s U.S. regulatory pathway following its earlier CE Mark approval.
Lloyd Diamond, CEO of Nitinotes, noted that the expertise at Gemelli is essential to validating the system’s performance. Alongside Prof. Boskoski, the research team includes Prof. Cristiano Spada and Dr. Vincenzo Bove. Nitinotes, a privately held firm based in Caesarea, Israel, secured CE Mark approval for the platform in November 2025 and is currently expanding its footprint in the European Union.
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