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

https://doi.org/10.1016/j.soard.2014.12.006Get rights and content

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/m2 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<.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.

Section snippets

Methods

The REDUCE Pivotal Trial was a prospective, sham-controlled, double-blinded, randomized multicenter clinical study that enrolled patients between August 13, 2012 and February 18, 2013. Participants were between the ages of 21 and 60 years of age with a baseline body mass index (BMI) of≥30 kg/m2 and≤40 kg/m2 with one or more obesity-related co-morbid conditions who provided written informed consent, were not at risk of pregnancy, and had failed to lose weight within the prior 36 months with a

Results

A total of 326 consented patients (187 DUO, 139 DIET) were randomized between August 13, 2012 and February 18, 2013 at 8 U.S. academic and community practice sites. Ninety percent (167 DUO patients and 126 DIET) of patients completed the 24 week randomized assessment period and all were assessed for primary endpoints as randomized. One-hundred-thirty-six (136) DUO patients went on to complete Weeks 24–48 of posttreatment follow-up for assessment of weight loss maintenance, and 77 DIET patients

Discussion

Novel treatments are needed to fill the treatment gap in obesity interventions [26]. Conventional therapies with diet and exercise have modest treatment effects and low compliance. Pharmacotherapy may be somewhat more effective, but to date has been hampered by cost, compliance failures, and concerns regarding adverse effects and the potential for congenital defects; the latter is a major concern given the preponderance of women of childbearing age in the target population. Bariatric surgery

Conclusion

The REDUCE Pivotal Trial of the ReShape Duo® Integrated Dual Balloon System in the treatment of patients with obesity demonstrated that the dual balloon is significantly more effective than diet and exercise alone in causing weight loss with a low adverse event profile. Treatment with the dual balloon supports diet compliance through 24 weeks, potentially allowing patients to relearn eating and exercise habits while undergoing an effective, low risk, reversible treatment with demonstrated

Disclosures

J. Ponce: ReShape Medical: consulting fees, funding for clinical research

G. Woodman: ReShape Medical: funding for clinical research

J. Swain: ReShape Medical: funding for clinical research

E. Wilson: ReShape Medical: funding for clinical research

W. English: ReShape Medical: funding for clinical research

S. Ikramuddin: ReShape Medical: funding for clinical research

E. Bour: ReShape Medical: funding for clinical research

S. Edmundowicz: ReShape Medical: funding for clinical research; GI Dynamics:

Acknowledgments

The Clinical Events and Data Monitoring Committee members were: Sreeni Jonnalagadda, M.D., FASGE (Chair), University of Missouri at Kansas City, Garth Jacobsen, M.D., FACS, UCSD Medical Center, Peter Denk, M.D., F.A.C.S., GI Surgical Specialists, PLLC, and Richard Chiacchierini, Ph.D., R. P. Chiacchierini & Associates, LLC. The REDUCE Pivotal Trial was supported financially by ReShape Medical. Monitoring was provided by ReShape Medical, Inc. with support from NAMSA (North American Science

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