Background and aims: Obesity is a global pandemic requiring effective interventions. Endoscopic bariatric therapies (EBTs) are minimally invasive alternatives to surgery. We compared three techniques of Endoscopic Gastroplasty (EG): endoscopic sleeve gastroplasty (ESG) (Apollo Overstitch Sx; Boston Scientific), endoluminal vertical gastroplasty (EVG) (Endomina; EndoTools Therapeutics), and primary obesity surgery endoluminal-2 (POSE-2) (Incisionless Operating Platform; USGI Medical). Methods: This was a single-center, randomized pragmatic study (ClinicalTrials.gov NCT04854317) involving patients who underwent EG through ESG or EVG or POSE-2. The primary endpoint was the percentage of total body weight loss (TBWL), with secondary endpoints assessing excess weight loss (EWL), safety, feasibility, anthropometric changes, metabolic and quality of life improvements. Results: Between April 2021 and May 2023, 184 obese patients (body mass index 36.5 ± 3.0 kg/m2) underwent EG. Follow-up rates were 56% at 6 months, 32% at 12 months, and 15% at 18 months. At 6, 12 and 18 months, patients experienced, respectively, 15.5% ± 6.0%, 14.5% ± 8.5% and 17.1% ± 10.2% TBWL and 39.3% ± 15.5%, 36.7% ± 21.4%, and 43.0% ± 26.6% EWL, with no statistically significant differences among the three techniques for both parameters (p ≥ 0.36). The technical success rate was 100%. The serious adverse event rate was 1.1%. Anthropometric measurements, body composition, fatty liver disease and hyperlipidemia improved at 6, 12 and 18-month follow-up, as well as the quality of life measured by Baros and TSD-OC test (p < 0.01). Conclusions: This study underscores the potential of EG through ESG, EVG, and POSE-2 as equally effective, safe, and feasible interventions for managing obesity at a medium-term follow-up. Results were consistent despite incomplete follow-up, the main study limitation, assuming data were missing at random.
Effects of different techniques of endoscopic gastroplasty on weight loss among patients with obesity: A randomized, single-center pragmatic trial / Vadalà Di Prampero, Salvatore F.; Geraci, Marco; Cosseddu, Valentina; Rocchi, Chiara; Bazzu, Paola; Simonelli, Ilaria; Fiorani, Marcello; Formichetti, Jessica; Manzoni, Gabriella; Di Maio, Federica; Massidda, Marco; Masia, Simona; Puci, Mariangela; Sotgiu, Giovanni; Milano, Valentina; Mancini, Maria A.; Rinaldi, Pierluigi M.; Giustacchini, Piero; Costamagna, Guido; Bulajic, Milutin. - In: GASTROINTESTINAL ENDOSCOPY. - ISSN 0016-5107. - (2025), pp. 1-28. [10.1016/j.gie.2025.12.271]
Effects of different techniques of endoscopic gastroplasty on weight loss among patients with obesity: A randomized, single-center pragmatic trial
Geraci, Marco;Rocchi, Chiara;Sotgiu, Giovanni;
2025
Abstract
Background and aims: Obesity is a global pandemic requiring effective interventions. Endoscopic bariatric therapies (EBTs) are minimally invasive alternatives to surgery. We compared three techniques of Endoscopic Gastroplasty (EG): endoscopic sleeve gastroplasty (ESG) (Apollo Overstitch Sx; Boston Scientific), endoluminal vertical gastroplasty (EVG) (Endomina; EndoTools Therapeutics), and primary obesity surgery endoluminal-2 (POSE-2) (Incisionless Operating Platform; USGI Medical). Methods: This was a single-center, randomized pragmatic study (ClinicalTrials.gov NCT04854317) involving patients who underwent EG through ESG or EVG or POSE-2. The primary endpoint was the percentage of total body weight loss (TBWL), with secondary endpoints assessing excess weight loss (EWL), safety, feasibility, anthropometric changes, metabolic and quality of life improvements. Results: Between April 2021 and May 2023, 184 obese patients (body mass index 36.5 ± 3.0 kg/m2) underwent EG. Follow-up rates were 56% at 6 months, 32% at 12 months, and 15% at 18 months. At 6, 12 and 18 months, patients experienced, respectively, 15.5% ± 6.0%, 14.5% ± 8.5% and 17.1% ± 10.2% TBWL and 39.3% ± 15.5%, 36.7% ± 21.4%, and 43.0% ± 26.6% EWL, with no statistically significant differences among the three techniques for both parameters (p ≥ 0.36). The technical success rate was 100%. The serious adverse event rate was 1.1%. Anthropometric measurements, body composition, fatty liver disease and hyperlipidemia improved at 6, 12 and 18-month follow-up, as well as the quality of life measured by Baros and TSD-OC test (p < 0.01). Conclusions: This study underscores the potential of EG through ESG, EVG, and POSE-2 as equally effective, safe, and feasible interventions for managing obesity at a medium-term follow-up. Results were consistent despite incomplete follow-up, the main study limitation, assuming data were missing at random.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
