Rachel L Moore1, Laura Eaton2, Julie Ellner3. 1. Surgical Specialists of Louisiana, New Orleans, LA, USA. dr.moore@whyweight.com. 2. UltaMed Corporation, Fort Lauderdale, FL, USA. 3. Ellner Bariatric, Inc., San Diego, CA, USA.
Abstract
BACKGROUND AND OBJECTIVES: Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting. METHODS AND MATERIALS: In this multicenter study, 258 adults with a body mass index of 30-40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%. RESULTS: The incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks). CONCLUSIONS: The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified. CLINICAL TRIAL REGISTRATION: CLINICAL TRIALS.GOV NCT02828657.
BACKGROUND AND OBJECTIVES: Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting. METHODS AND MATERIALS: In this multicenter study, 258 adults with a body mass index of 30-40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%. RESULTS: The incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks). CONCLUSIONS: The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified. CLINICAL TRIAL REGISTRATION: CLINICAL TRIALS.GOV NCT02828657.
Authors: A Genco; T Bruni; S B Doldi; P Forestieri; M Marino; L Busetto; C Giardiello; L Angrisani; L Pecchioli; P Stornelli; F Puglisi; M Alkilani; A Nigri; N Di Lorenzo; F Furbetta; A Cascardo; M Cipriano; M Lorenzo; N Basso Journal: Obes Surg Date: 2005-09 Impact factor: 4.129
Authors: J Herve; C H Wahlen; A Schaeken; B Dallemagne; J M Dewandre; S Markiewicz; B Monami; J Weerts; C Jehaes Journal: Obes Surg Date: 2005 Jun-Jul Impact factor: 4.129
Authors: Nicola Crea; Giacomo Pata; Domenico Della Casa; Luigi Minelli; Giovanni Maifredi; Ernesto Di Betta; Francesco Mittempergher Journal: Obes Surg Date: 2009-06-09 Impact factor: 4.129