Nitinotes has commenced its US investigational device exemption (IDE) Endoscopic Automated Sleeve Evaluation (EASE) clinical trial, with the first patient treated using the EndoZip automated suturing system for endoscopic sleeve gastroplasty (ESG).
The procedure was carried out at Lenox Hill Hospital | Northwell Health in New York, marking the inaugural activated US site for the study.
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ESG is a weight-loss procedure that involves decreasing stomach size using an endoscope and internal sutures, without external incisions.
EndoZip is a minimally invasive suturing system designed to deliver restrictive sutures to the stomach wall.
The two-arm, multi-centre, randomised, prospective, blinded pivotal trial will assess the effectiveness and safety of the EndoZip automated ESG procedure against the manual Apollo OverStitch ESG procedure.
It will also evaluate physician-reported outcomes, focusing on procedural experience, workflow efficiency and ease of use.
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By GlobalDataUp to 184 patients are expected to be enrolled across as many as ten clinical sites in Europe and the US, with a follow-up period of 12 months.
The study was developed in accordance with the US Food and Drug Administration (FDA) guidance and is intended to support a future regulatory submission in the country.
Additional clinical sites are anticipated to commence enrolment in the coming months.
EndoZip recently secured CE Mark approval, allowing its commercial launch in the European Union and other markets that recognise the CE Mark.
The trial’s US investigator Dr Steven Shamah said: “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.
“There is a significant treatment gap between glucagon-like peptide-1 (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.”
