EndoZip (Nitinotes Ltd, Cesarea, Israel) is a fully automated, operator-independent robotic endoscopic suturing device developed for gastric volume reduction and treatment of obesity. We aim to assess the efficacy and safety of EndoZip to treat patients with obesity.

We conducted a prospective multicenter study and recruited 45 patients with a body mass index of 30 to 40 kg/m². Our primary outcome was to assess the percentage of total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the Influence of Weight on the Quality of Life questionnaire at 1 year.

The mean ± standard deviation age was 44.2 ± 8.8 years, and the mean ± standard deviation body mass index was 34.5 ± 2.9 kg/m². A majority (90.7%) of patients were female. The procedure was technically successful in all patients (100%). A median of 4 (range, 3-5) full-thickness sutures were placed, and the mean procedure time was 30.8 ± 15.8 minutes. At 12 months, the mean %TBWL was 13.21 (95% confidence interval, 10.11-16.31), and 76.6% of patients achieved ≥5% TBWL. We observed significant reduction in waist circumference, glycated hemoglobin, and alanine aminotransferase levels at 12 months (P < .001). We found a significant improvement in quality of life at 12 months (51.28 ± 16.22 vs 35.8 ± 11.9, P < .001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day.

Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and improvement in quality of life. (Clinical trial registration number: NCT04773795.)