Robotic Endoscopic Sleeve Gastroplasty for the Treatment of Obesity: An Interim Analysis of a Multicenter Pilot Study

Introduction: Endoscopic gastric volume reduction is a safe and effective technique for inducing weight loss in patients with obesity. They function mainly by inducing satiation and satiety and impacting gastric motility. However, the technical success of the procedure is primarily influenced by the operator's skills. The available endoscopic techniques have a significant learning curve to achieve mastery over the technique. Robotic endoscopy promises to overcome the learning curve limitation and minimize operator variation. Our early experience with automated robotic endoscopy (EndoZipTM, Nitinotes, Israel) for endoscopic gastric volume reduction has been shown to be safe. The device has been made more sophisticated and fully automated with multiple iterations (Figure 1). We aim to present the safety and efficacy of the newer, fully automated robotic endoscopic suturing system for obesity. Methods: This multicenter, prospective, single-arm study aimed to assess the safety and efficacy of the EndoZip™ system for the treatment of obesity. Patients with a BMI of 30 to 40 kg/m 2 unable to lose weight with non-invasive approaches and deemed suitable for bariatric endoscopic according to the multidisciplinary team were enrolled in 3 centers (Spain, Italy, and Israel). The efficacy of the EndoZip™ system was assessed. %TBWL, and % of patients with %TBWL ≥5% were evaluated via ANCOVA model. Safety data and physician's satisfaction with device use were evaluated via descriptive statistics. Results: Forty-five patients underwent robotic endoscopy-assisted gastric volume reduction. The mean ±SD age was 44 ±8 years, and BMI was 34.6 ±2.9 kg/m2, respectively. The majority of the patients were female (89%). the average procedure time was 30 minutes. We used an average of 3.9 sutures; At 12 months, the mean ±SD %TBWL was 13.5 ± 10.4%. We observed >5% TBWL in 79.4% of the patients (Table 1). All endoscopists found the device easy to use. Serious adverse events occurred in 2 patients (bleeding and gastric perforation). The bleeding was stopped with endoscopic clipping, and the gastric perforation required surgical closure. No mortality occurred. Conclusion: Robotic endoscopic suturing using the automated EndozipTM system is safe, user-friendly, and effective in inducing weight loss in patients with obesity.Figure 1.: EndoZIp Disposable Device. Table 1. - ANCOVA model weight loss results ANCOVA model results 1 month 2 months 4 months 6 months 12 months Adj. mean of %TBWL (lower 95% CL) 7.4% (6.6%) 10.3% (8.9%) 13.3% (11.5%) 14.5% (11.7%) 13.5% (10.4%) % of patients with TBWL ≥5% at 12 months (lower 95% CL) 78.6% (63.2%) 92.7% (80.1%) 92.3% (79.1%) 85.0% (70.2%) 79.4% (62.1%) Per protocol analysis.