First In Human Results Of Endozip, A Novel Suturing Bariatric Endoscopy Procedure

Abstract

Background & Aims: Bariatric Endoscopic techniques (BET) have emerged to provide a treatment option for weight loss and associated comorbidities, to the actual burden of untreated obese patients. A novel bariatric endoscopy gastroplasty, fully automated, more operator independent, minimally -invasive suturing system, called Endozip (Figure 1), enables to create multiple internal gastric walls segmentations by forming wall-wall full thickness suture of the stomach. A prospective First in human open label single center study was carried out to assess Endozip procedure in terms of safety, feasibility and efficacy. Methods: 13 patients (61.5% male; mean age 41 y, mean initial BMI 36.1 kg/m2 (range 30-39) underwent Endozip procedure between May and November 2018, in the Bariatric Endoscopy Unit of Madrid HM Sanchinarro University Hospital. Durability of the procedure was scheduled for endoscopic assessment at 1 and 6 months postprocedure. The primary outcome was the procedure safety and feasibility. The secondary outcomes were weight loss outcomes, measured by TBWL (total body weight loss), %TBWL and % excess weight loss (%EWL) at 1,3 and 6 months of follow-up. Results: There were no intra-procedural nor early serious adverse events. All patients were discharged the day after the procedure. The average procedure time evolved from 120 min for the first 3 patients to 35 min for the last 3 patients). The average number of full thickness automatic sutures placed was 2.6 (range 2-3). TBWL, %TBWL and %EWL were: at 1 month (n=10): 9.3 kg, 8.9% and 33.4% respectively; at 3 month (n=6): 11.8 kg, 11.5% and 46.1% respectively and at 6 month (n=2): 20.9 kg, 20.9% and 95.3%. At 1 month endoscopic control showed that sutures were in place (Figure 2). The study is ongoing Conclusions: Endozip™ procedure allows a minimally invasive automated suturing of the stomach. First in human results showed safety, feasibility and effectiveness in a short duration procedure. Some evolution in navigation and visibility will be key to include this procedure in the available bariatric endoscopy techniques.