Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study.

INTRODUCTION: Endoscopic gastroplasty and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study is to assess the feasibility and safety of a novel fully automated, operator-independent endoscopic suturing system (EndoZip™) for minimally invasive treatment of obesity. DESIGN: Single-center pilot feasibility study. PATIENTS: Eleven patients with a body mass index (BMI) of 30 to 40 kg/m2 with or without obesity-associated comorbidity. INTERVENTIONS: Gastric volume reduction with EndoZip™ system. MAIN OUTCOME MEASUREMENTS: Primary outcome was to assess the technical feasibility and safety. The secondary outcome was to determine %total body weight loss (TBWL) and %excess weight loss (EWL) at 6 months. RESULTS: The mean ± SD age was 42.7 ± 5.6 years, and the mean ± SD BMI was 36.9 ± 2.8 kg/m2. A majority (64%) were men. The procedure was technically successful (100%) in all patients. A median of 3 (range, 2-4) full-thickness sutures were placed, and the mean procedure time was 54.6 ± 23.9 (23-100) min. No immediate complications occurred, and all were discharged in 24 h. One patient developed respiratory infection 3 days after the procedure and required hospitalization. The infection was mild and resolved with antibiotic treatment. At 6-month follow-up, the mean ± SD TBWL, %TBWL, and %EWL were 17.8 ± 6.7 kg, 16.2 ± 6.0%, and 54.3 ± 28.4%, respectively (p < 0.001). LIMITATIONS: Limited number of patients. CONCLUSION: Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising. An extended feasibility study on a larger sample size is being planned (Clinicaltrials.gov. NCT03472196).

Bariatric endoscopy procedure type or follow-up: What predicted success at 1 year in 962 obese patients?

Background and study aims It is uncertain if the difference in weight loss outcomes between different endoscopic bariatric therapies (EBTs) is technique-related or multidisciplinary team (MDT) follow-up-related. We hypothesized that at 1 year, the weight loss is determined more by adherence to MDT follow-up than by procedure type. We aimed to compare 1 year weight loss outcomes of four different EBTs at a single center with a standardized MDT follow-up. Patients and methods We prospectively collected and retrospectively analyzed outcomes in 962 patients (female-691, 71.2 %; mean age, 44.8 ±â€Š10.6 years, mean BMI, 37.8 ±â€Š5.9 Kg/m 2 ) treated with Intragastric balloons (IGBs) or endoscopic gastroplasty (EG) at HM Sanchinarro University Hospital between March 2012 to January 2017. The procedures were performed by the same endoscopist and followed up by the same MDT. We compared the percentage total body weight loss (%TWBL) at 1 year. We performed linear and logistic regression to identify predictive factors for weight loss and follow-up adherence at 1 year. Results Four hundred and eighty-one IGBs (Orbera-80.9 %; ReShape Duo-19.1 %), and 481 EG (Apollo ESG-51.3 %; Primary obesity surgery endoluminal-POSE-48.6 %) were performed. Only 480 patients (IGB- 45 %; EG- 55 %) completed 1 year follow-up. Among them, Apollo ESG achieved significantly higher TBWL (19.5 ±â€Š13 %, P  = 0.035), %TBWL (17.4 ±â€Š10.2 %, P  = 0.025), and ≥ 20 % TBWL (36.7 %, P  = 0.032). However, in linear regression after adjusting for variables, only higher initial BMI (B = 0.31, P  < 0.001) and higher percentage follow-up attendance (B = 0.24, P  < 0.001) significantly predicted %TBWL at 1 year in the completion group but not the procedure type (B = 0.02, P  = 0.72). In logistic regression, we observed female sex ( P  = 0.01), high initial BMI ( P  < 0.001), endoscopic gastroplasty ( P  = 0.04), and high 1-month %TBWL ( P  < 0.001) significantly predicted follow-up completion at 1 year. Conclusions Weight loss at 1 year is dependent on MDT follow-up rather than procedure type. Endoscopic gastroplasty promoted follow-up adherence more than IGBs.