Introduction
EndoZipTM is a fully automated endoscopic suturing device designed to reduce gastric volume for obesity treatment, minimizing the operator-dependence for endoscopic gastroplasty. A recent multicenter clinical trial showed that the device is easy-to-use, safe, and effective for treating class I and II obesity. In this study, we aim to assess the efficacy and safety of EndoZipTM to facilitate improvement in patients with obesity-related comorbidities.
Aims & Methods
This is the analysis, including the Italian site only, of a prospective, single-arm, open-label, clinical trial including patients with a BMI of 30-42 kg/m2 and hypertension and/or type 2 diabetes mellitus (T2DM) who failed non-invasive weight-loss therapies and were deemed suitable for bariatric endoscopy according to the multidisciplinary team.
We report the percentage of total body weight loss (%TBWL), changes in Hb1AC and/or Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), changes in ambulatory blood pressure monitor (ABPM), and/or treatment for hypertension following automatic endoscopic procedure. Incidence of adverse events was also recorded.
Patients’ clinical health conditions were evaluated at 6 and 12 months as compared to baseline and classified as “Improved”, “No change”, or “Worsened”.
Results
Twenty patients (80% female, mean age 51.9±9.8, mean BMI 34.9±3.2 kg/m2) were enrolled at a single tertiary center. Five patients (25%) had both hypertension and T2DM, eleven (55%) had only hypertension, and four (20%) had only T2DM. One patient with hypertension was lost to follow-up.
At 12 months, the mean %TBWL was 11.4% (with SE 1.1%). Among patients with T2DM, improvement was observed in all subjects at 6 months. At 12 months, 5 out of 8 (62.5%) showed an improvement in their diabetes health condition, 2 out of 8 (25%) showed no change, and one patient experienced worsening in HbA1c and HOMA-IR. In the group of patients with hypertension, 7 out of 13 (54%) showed an improvement in ABPM values and/or in their hypertension medication. Meanwhile, 4 out of 13 (31%) experienced no change, and in 2 out of 13 (15%), there was a worsening of their condition. In these two cases, the patients had discontinued an antihypertensive medication. One anticipated severe adverse event, immediate post-procedure bleeding, was reported. The event was effectively managed endoscopically with a single clip and a 2 mL injection of fibrin glue, without the need for blood transfusion. No pathologies were identified in the esophagus, and the sutures in the stomach were found to be intact.
Conclusion
Based on these preliminary results, automatic endoscopic gastroplasty seems to be safe and promising for the treatment of obesity and associated comorbidities such as hypertension and T2DM.
References
Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21. PMID: 39307402.
