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

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 ¼ 326) with body mass index (BMI) 30–40 kg/m 2 were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n ¼ 187) or sham endoscopy plus diet and exercise alone (DIET, n ¼ 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 ¼ 167) compared with DIET patients (11.3% ITT ,P ¼ .004, 12.3% CC, n ¼ 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P o .001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). Conclusion: The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile. (Surg Obes Relat Dis 2015;11:874–881.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.