title: 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.
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.
authors: Chattanooga Bariatrics, Chattanooga, TN, and Hamilton Weight Management Center, Hamilton Medical Center, Dalton, GA. Electronic address: JPonceMD@gmail.com.
authors: Jaime
authors: J
authors: Ponce
authors: MidSouth Bariatrics, Memphis, TN, and Baptist Memorial Hospital, Memphis, TN.
authors: George
authors: G
authors: Woodman
authors: Scottsdale Healthcare Bariatric Center, Scottsdale Healthcare System, Scottsdale, AZ.
authors: James
authors: J
authors: Swain
authors: Department of Surgery, University of Texas Medical School at Houston, Houston, TX.
authors: Erik
authors: E
authors: Wilson
authors: Department of Surgery, Marquette General Hospital, Marquette, MI.
authors: Wayne
authors: W
authors: English
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: Sayeed
authors: S
authors: Ikramuddin
authors: Department of Surgery, Greenville Health System, Greenville, SC.
authors: Eric
authors: E
authors: Bour
authors: Division of Gastroenterology, Washington University, St Louis, MO.
authors: Steven
authors: S
authors: Edmundowicz
authors: Department of Surgery, University of Texas Medical School at Houston, Houston, TX.
authors: Brad
authors: B
authors: Snyder
authors: Department of Surgery, Marquette General Hospital, Marquette, MI.
authors: Flavia
authors: F
authors: Soto
authors: Division of Gastroenterology, Washington University, St Louis, MO.
authors: Shelby
authors: S
authors: Sullivan
authors: ReShape Medical, Inc., San Clemente, CA.
authors: Richard
authors: R
authors: Holcomb
authors: ReShape Medical, Inc., San Clemente, CA.
authors: John
authors: J
authors: Lehmann
mesh_terms: D000328:Adult; D015992:Body Mass Index; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D015905:Gastric Balloon; D005773:Gastroscopy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D015431:Weight Loss / Q000502:physiology*; D055815:Young Adult
keywords: Endoscopic bariatric therapy; Intragastric balloon; Nonsurgical weight loss; Obesity; Randomized controlled trial; Weight loss therapy