First patient treated in EASE clinical trial evaluating the EndoZip Automated Suturing System for ESG

The first patient has been treated in Nitinotes’ US Investigational Device Exemption (IDE) EASE Clinical Trial evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure was performed at Lenox Hill Hospital | Northwell Health in New York, NY, the trial's first activated US site.

The EASE Clinical Trial is a prospective, multi-centre, randomised, two-arm, blinded pivotal study designed to evaluate the safety and effectiveness of the EndoZip automated ESG procedure, compared with the manual Apollo OverStitch® ESG procedure. In addition to clinical endpoints, the study will also assess physician-reported outcomes related to procedural experience, including ease of use and workflow efficiency.  The study plans to enrol up to 184 patients across up to ten clinical sites in the US and Europe, with 12-month follow-up. The IDE study was designed in alignment with FDA guidance and is intended to support a future US regulatory submission.

"Treating the first patient in the EASE trial represents an important milestone for the ESG community. For the first time, a randomised study will compare an automated, single-operator ESG approach to a widely adopted manual suturing technique,” said Dr Steven Shamah, a lead US investigator for the trial. “There is a significant treatment gap between GLP-1 therapy, which has high dropout rates, and invasive bariatric surgery. ESG offers an important alternative, and rigorously generated clinical evidence will be essential to guide practice and expand treatment options."

Additional clinical sites are expected to initiate enrolment in the coming months.

"Our mission is to advance the role of automation in obesity treatment by generating high-quality clinical evidence that informs regulatory review and enables broader clinical adoption," added Lloyd Diamond, CEO of Nitinotes. "The first patient treated in the EASE trial is a significant step forward in that mission and builds on the momentum of our recent CE Mark approval."

EndoZip has received CE Mark approval, authorising commercial launch in the European Union and other CE Mark–accepting markets. EndoZip is investigational in the US and is limited by Federal (or United States) law to investigational use.