The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity

Abstract Background Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. Objective: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. Setting: Academic and community practice, United States. Methods Participants (n = 326) with body mass index (BMI) 30–40 kg/m 2 were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n=187) or sham endoscopy plus diet and exercise alone (DIET, n=139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. Results Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n=167) compared with DIET patients (11.3% ITT , P = .004, 12.3% CC, n=126). DUO patients significantly exceeded a 35% response rate (49.1% ITT , P Conclusion The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.