BACKGROUND AND STUDY AIMS: Bariatric surgical treatments have been proven to induce long-term weight loss in morbidly obese patients, but complications are relatively frequent. We recently reported a first human multicenter trial assessing the safety, feasibility, and weight loss results of the Transoral Gastroplasty (TOGA) system (Satiety Inc., Palo Alto, CA) at 6 months. Here we report the 6-month results of the second phase of the pilot trial with the TOGA system, with technical improvements to the device. PATIENTS AND METHODS: Patients met established criteria for bariatric surgery. The TOGA system, a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curvature of the stomach. Follow-up was at 1 week and at 1, 3, and 6 months. At 3 months, re-treatment consisting in additional distal restrictions was allowed if necessary. RESULTS: Data were available for 11 patients in our center (7 female, mean age 44.2 years, mean body mass index 41.6). The procedure was completed safely in all patients. There were no serious adverse events. Mean excess weight loss was 19.2 %, 33.7 %, and 46.0 % at 1, 3, and 6 months, respectively. Average body mass index decreased from 41.6 before treatment to 33.1 at 6 months. Absolute mean weight loss was 9.9 kg, 17.5 kg, and 24.0 kg at 1, 3, and 6 months, respectively. A dramatic improvement in quality-of-life measures was observed in all patients. CONCLUSIONS: This second pilot trial confirmed the feasibility and safety of transoral gastroplasty. The early results and technical improvements reported in the present study are encouraging in terms of safety, early weight loss, and quality of life, and clearly allowed multicenter trials, which are planned to start soon.
BACKGROUND AND STUDY AIMS: Bariatric surgical treatments have been proven to induce long-term weight loss in morbidly obesepatients, but complications are relatively frequent. We recently reported a first human multicenter trial assessing the safety, feasibility, and weight loss results of the Transoral Gastroplasty (TOGA) system (Satiety Inc., Palo Alto, CA) at 6 months. Here we report the 6-month results of the second phase of the pilot trial with the TOGA system, with technical improvements to the device. PATIENTS AND METHODS: Patients met established criteria for bariatric surgery. The TOGA system, a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curvature of the stomach. Follow-up was at 1 week and at 1, 3, and 6 months. At 3 months, re-treatment consisting in additional distal restrictions was allowed if necessary. RESULTS: Data were available for 11 patients in our center (7 female, mean age 44.2 years, mean body mass index 41.6). The procedure was completed safely in all patients. There were no serious adverse events. Mean excess weight loss was 19.2 %, 33.7 %, and 46.0 % at 1, 3, and 6 months, respectively. Average body mass index decreased from 41.6 before treatment to 33.1 at 6 months. Absolute mean weight loss was 9.9 kg, 17.5 kg, and 24.0 kg at 1, 3, and 6 months, respectively. A dramatic improvement in quality-of-life measures was observed in all patients. CONCLUSIONS: This second pilot trial confirmed the feasibility and safety of transoral gastroplasty. The early results and technical improvements reported in the present study are encouraging in terms of safety, early weight loss, and quality of life, and clearly allowed multicenter trials, which are planned to start soon.
Authors: Ben Gys; Philip Plaeke; Bas Lamme; Thierry Lafullarde; Niels Komen; Anthony Beunis; Guy Hubens Journal: Obes Surg Date: 2019-09 Impact factor: 4.129
Authors: Giuseppe Nanni; Pietro Familiari; Alessandro Mor; Amerigo Iaconelli; Vincenzo Perri; Francesco Rubino; Giuseppe Boldrini; Maria Paola Salerno; Laura Leccesi; Samuele Iesari; Liliana Sollazzi; Valter Perilli; Marco Castagneto; Gertrude Mingrone; Guido Costamagna Journal: Obes Surg Date: 2012-12 Impact factor: 4.129