Automatic Endoscopic Gastroplasty For The Treatment of Obesity: Results from A Prospective Multicenter Study.

Background and Aims: EndoZip ^TM 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 ^TM to treat patients with obesity.
Methods: We conducted a prospective multicenter study and recruited 45 patients with a BMI of 30-40 kg/m ² . Our primary outcome was to assess the percentage total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the IWQOL questionnaire at 1 year.
Results: The mean ±SD age was 44.2 ± 8.8 years, and the mean ±SD BMI was 34.5 ± 2.9 Kg/m ² . A majority (90.7%) 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% CI: 10.11- 16.31%) and 76.6% of patients achieved >5% TBWL. We observed significant reduction in waist circumference, HbA1C, and ALT levels at 12 months (p<0.001). We found a significant improvement in quality of life at 12 months (51.28 ±16.22 vs. 35.8±11.9, p<0.001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day.
Conclusion: Our first-in-human study showed that the Endozip ^TM device is safe and effective in treating obesity. The weight loss led to comorbid changes and improvement in quality of life (Clinicaltrials.gov, NCT04773795).
(Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)