EndoZip^TM is a fully automated endoscopic suturing device designed to reduce gastric volume for obesity treatment, decreasing operator dependence during endoscopic gastroplasty. A recent multicenter clinical trial demonstrated that the device is easy to use, safe, and effective for treating class I and II obesity. This analysis focuses on ouycomes from the Italian site, evaluating the efficacy and safety of EndoZip^TM system in improving obesity-related comorbidities.

This prospective, single-arm, open-label clinical trial enrolled patients with BMI 30-42g/m² and hypertension and/or type 2 diabetes mellitus (T2DM) who failed non-invasive weight-loss therapies and were suitable candidates for bariatric endoscopy. Endpoints include percentage total body weight loss (%TBWL), changes in T2DM (HbA1c and/or HOMA-IR index), and changes in hypertension (blood pressure reduction by 24-hours ambulatory blood pressure monitor (ABPM) and/or reduction of antihypertensive medication/dosage) at 12 months post-procedure. The incidence of adverse events, changes in Fibroscan parameters (CAP score and fibrosis) and Weight-related Quality of Life (IWQOL) Questionnaire scores.

Twenty patients (80% female, mean age 51.9±9.8 years, mean BMI 34.8±3.2 kg/m²) were enrolled at a single tertiary center. Comorbidity distribution included five patients (25%) with both hypertension and T2DM, eleven (55%) with hypertension alone, and four (20%) with T2DM alone. The mean adjusted %TBWL at 12 months was 11.4% (95% CI: 9.1%–13.6%). Among patients with hypertension, 53.8% showed improvement, 30.8% showed no change, and 15.4% worsened. In all worsening cases, the antihypertensive medication has been discontinued. Among patients with T2DM, 62.5% showed improvement, 25.1% showed no change, and 12.5% worsened. Fibroscan demonstrated a significant improvement in steatosis (CAP score: 314±47.9 at baseline vs. 263±54.6 at 12 months, p=0.0048), while fibrosis changes from baseline were not statistically significant (5.5±1.7 kPa vs. 5±1 kPa, p=0.1510). The mean IWQOL score at 12 months increased by more than 12 points from baseline (14.2 points±11.6), indicating a meaningful improvement in patients' quality of life. One severe adverse event occurred—bleeding that was effectively managed by endoscopic hemostasis. 

EndoZip demonstrates effective weight-loss outcomes and meaningful improvement in obesity-related comorbidities at 12 months. The procedure also leads to significant improvement in patient quality of life. The safety profile is consistent with expectations for endoscopic gastroplasty, supporting EndoZip as a safe and effective minimally invasive option for patients with class I–II obesity.