Automatic Endoscopic Gastroplasty For The Treatment Of Obesity And Associated Comorbidities: An Interim Analysis Of A Prospective Clinical Trial

Aims EndoZip 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 safe and effective for the treatment of class I and II obesity¹. In this study, we aim to assess the efficacy and safety of EndoZip to treat patients with obesity-related comorbidities.

Methods This an interim analysis of a prospective, single-arm, open-label, clinical trial including patients with BMI of 30-42g/m² and hypertension and/or type 2 diabetes mellitus (T2DM) who failed non-invasive weight-loss therapies and deemed suitable for bariatric endoscopy according to the multidisciplinary team. We report percentage of total body weight loss (%TBWL), changes in Hb1AC, changes in ambulatory blood pressure monitor (ABPM) following automatic endoscopic procedure. Incidence of adverse events was also recorded [1]. A correlation between weight loss, categorized as “%TBWL<5%=Unchanged”, “%TBWL 5%-10%=modest Weight Loss “, and “%TBWL>10%=significant weight loss”, and changes in comorbidities have been explored by using Chi-Square test.

Results Twenty patients (80% female, mean age 51.9±9.6, mean BMI 34.8±3.1 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 6-months, the mean%TBWL was 11.9%±5.0. Among the patients with hypertension, 6/15 (40.0%) showed an improvement in ABPM values, 7/15 (46.7%) showed no change, and in 2/15 (13.3%) cases, there was a worsening of ABPM values. In these latter two cases, the patients had discontinued an antihypertensive medication. 7/9 (77.8%) patients with T2DM showed an improvement of Hb1AC (range Δ 0.5-2.5) and 2/9 (22.2%) showed no variation. No correlation between weight loss and ABPM changes (P=0.196) and Hb1AC changes (P=0.571) were observed. One moderate adverse event occurred, namely a bleeding that was effectively managed by endoscopic hemostasis.

Conclusions 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. While a formal correlation could not be established due to the limited sample size, a strong trend of improvement in T2DM outcomes was observed.

 

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Conflicts of Interest

Ivo Boskoski is a consultant for Apollo Endosurgery, Boston Scientific, Nitinotes, Pentax, Cook Medical, Microtech, ERBE, Siemens, Myka labs, and Endo Tools Therapeutics S.A., conducts sponsored lectures for Apollo Endosurgery, Boston Scientific, Cook Medical, Microtech, is recipient of research grant from Apollo Endosurgery, Endo Tool Therapeutics, and ERBE, and is scientific advisory board member for Nitinotes and Myka labs. Cristiano Spada is a consultant for Medtronic and AnX Robotics and received speaker’s fees from Olympus and Pentax.

• References

• 1 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 2024; S0016-5107 (24) 03508-9 Epub ahead of print. PMID: 39307402

Publication History

Article published online:
27 March 2025