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Surg Obes Relat Dis. 2015 Jul-Aug;11(4):874-81. doi: 10.1016/j.soard.2014.12.006. Epub 2014 Dec 16.

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

Author information

1
Chattanooga Bariatrics, Chattanooga, TN, and Hamilton Weight Management Center, Hamilton Medical Center, Dalton, GA. Electronic address: JPonceMD@gmail.com.
2
MidSouth Bariatrics, Memphis, TN, and Baptist Memorial Hospital, Memphis, TN.
3
Scottsdale Healthcare Bariatric Center, Scottsdale Healthcare System, Scottsdale, AZ.
4
Department of Surgery, University of Texas Medical School at Houston, Houston, TX.
5
Department of Surgery, Marquette General Hospital, Marquette, MI.
6
Department of Surgery, University of Minnesota, Minneapolis, MN.
7
Department of Surgery, Greenville Health System, Greenville, SC.
8
Division of Gastroenterology, Washington University, St Louis, MO.
9
ReShape Medical, Inc., San Clemente, CA.

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<.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.

KEYWORDS:

Endoscopic bariatric therapy; Intragastric balloon; Nonsurgical weight loss; Obesity; Randomized controlled trial; Weight loss therapy

PMID:
25868829
DOI:
10.1016/j.soard.2014.12.006
[Indexed for MEDLINE]

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