Nitinotes Initiates Pivotal EASE Trial for Automated Endoscopic Sleeve Gastroplasty System
核心洞察
Nitinotes (搜索) has treated the first patient in its pivotal EASE Clinical Trial, evaluating the EndoZip (搜索) automated suturing system for endoscopic sleeve gastroplasty at Lenox Hill Hospital (搜索) in New York.
The randomized, multicenter study will compare automated ESG to manual suturing techniques across up to 184 patients at 10 sites in the US and Europe over 12 months.
This IDE study represents the first randomized comparison of automated versus manual ESG approaches and is designed to support future FDA regulatory submission.
Nitinotes (搜索) Ltd. has achieved a significant regulatory milestone with the treatment of the first patient in its pivotal EASE Clinical Trial, marking the beginning of a comprehensive evaluation of automated endoscopic sleeve gastroplasty technology. The procedure was performed at Lenox Hill Hospital (搜索) | Northwell Health in New York, representing the trial's first activated U.S. site.
The EASE (Endoscopic Automated Sleeve Evaluation) Clinical Trial is a prospective, multicenter, randomized, two-arm, blinded pivotal study designed to evaluate the safety and effectiveness of the EndoZip (搜索) Automated Suturing System compared with the manual Apollo OverStitch (搜索) ESG procedure. This marks the first randomized study to compare an automated, single-operator ESG approach to a widely adopted manual suturing technique.
Addressing Critical Treatment Gaps
Obesity affects more than 650 million adults worldwide and remains a leading driver of metabolic diseases, with many patients unable to achieve durable weight loss through lifestyle changes or medical therapy alone. ESG has emerged as an important minimally invasive option, and interest continues to grow in technologies that can enhance usability, standardization and consistency of procedural delivery.
Dr. Steven Shamah, a lead U.S. investigator for the trial, emphasized the clinical significance: "There is a significant treatment gap between GLP-1 (搜索) 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."
Trial Design and Regulatory Strategy
The study plans to enroll up to 184 patients across up to 10 clinical sites in the United States and Europe, with 12-month follow-up. In addition to clinical endpoints, the study will assess physician-reported outcomes related to procedural experience, including ease of use and workflow efficiency. The IDE study was designed in alignment with FDA guidance and is intended to support a future U.S. regulatory submission.
Lloyd Diamond, CEO of Nitinotes (搜索), stated: "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. 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."
Commercial Progress and Market Access
The first-patient milestone follows the recent CE Mark approval of EndoZip (搜索), enabling commercial launch in the European Union and other CE Mark-accepting markets. EndoZip is investigational in the United States and is limited by Federal law to investigational use.
Nitinotes (搜索) is an early commercial stage, privately held medical device company pioneering automated endoluminal suturing technologies for the treatment of obesity. The company's flagship system, EndoZip (搜索), is a fully automated ESG platform designed to support a standardized approach to endoluminal suturing.
Additional clinical sites are expected to initiate enrollment in the coming months as the company advances toward its regulatory objectives and broader clinical adoption of automated ESG technology.