title: Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.
abstract: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling.
  
  
  
  In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m2were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss.
  
  
  
  At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group.
  
  
  
  The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Thompson
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Barham K
authors.initials: BK
authors.lastname: Abu Dayyeh
authors.affiliation: Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Kushner
authors.affiliation: Division of Gastroenterology, Washington University in St Louis, St Louis, Missouri, USA.
authors.forename: Shelby
authors.initials: S
authors.lastname: Sullivan
authors.affiliation: Division of Endocrinology, St Mary Medical Center, Langhorne, Pennsylvania, USA.
authors.forename: Alan B
authors.initials: AB
authors.lastname: Schorr
authors.affiliation: Division of Endocrinology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Anastassia
authors.initials: A
authors.lastname: Amaro
authors.affiliation: Nutrition and Weight Management Center, Boston Medical Center, Boston, Massachusetts, USA.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Apovian
authors.affiliation: Division of Minimally Invasive and Bariatric Surgery, Howard University, Washington, District of Columbia, USA.
authors.forename: Terrence
authors.initials: T
authors.lastname: Fullum
authors.affiliation: Division of Gastroenterology, University of California, San Diego, California, USA.
authors.forename: Amir
authors.initials: A
authors.lastname: Zarrinpar
authors.affiliation: Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Jensen
authors.affiliation: Division of Gastroenterology and Hepatology, Northwestern University School of Medicine, Chicago, Illinois, USA.
authors.forename: Adam C
authors.initials: AC
authors.lastname: Stein
authors.affiliation: Washington University in St Louis, St Louis, Missouri, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Edmundowicz
authors.affiliation: Division of Gastroenterology, Weill Cornell Medical College, New York, New York, USA.
authors.forename: Michel
authors.initials: M
authors.lastname: Kahaleh
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Marvin
authors.initials: M
authors.lastname: Ryou
authors.affiliation: Division of Gastroenterology, St Mary Medical Center, Langhorne, Pennsylvania, USA.
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Bohning
authors.affiliation: Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Ginsberg
authors.affiliation: Section of Gastroenterology, Boston Medical Center, Boston, Massachusetts, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Huang
authors.affiliation: Center for Wellness and Weight Loss Surgery, Howard University, Washington, District of Columbia, USA.
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Tran
authors.affiliation: VA San Diego Healthcare System, San Diego, California, USA.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Glaser
authors.affiliation: Northwestern University School of Medicine, Chicago, Illinois, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Martin
authors.affiliation: Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Jaffe
authors.affiliation: Section of Gastroenterology, Boston Medical Center, Boston, Massachusetts, USA.
authors.forename: Francis A
authors.initials: FA
authors.lastname: Farraye
authors.affiliation: Section of Gastroenterology, VA San Diego Healthcare System, San Diego, California, USA.
authors.forename: Samuel B
authors.initials: SB
authors.lastname: Ho
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Kumar
authors.affiliation: Northwestern University School of Medicine, Chicago, Illinois, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Harakal
authors.affiliation: Washington University in St Louis, St Louis, Missouri, USA.
authors.forename: Meredith
authors.initials: M
authors.lastname: Young
authors.affiliation: Weill Cornell Medical College, New York, New York, USA.
authors.forename: Catherine E
authors.initials: CE
authors.lastname: Thomas
authors.affiliation: Weill Cornell Medical College, New York, New York, USA.
authors.forename: Alpana P
authors.initials: AP
authors.lastname: Shukla
authors.affiliation: Brigham and Women's Hospital, Boston, Masachusetts, USA.
authors.forename: Michele B
authors.initials: MB
authors.lastname: Ryan
authors.affiliation: St Mary Medical Center, Langhorne, Pennsylvania, USA.
authors.forename: Miki
authors.initials: M
authors.lastname: Haas
authors.affiliation: Aspire Bariatrics, Inc., King of Prussia, Pennsylvania, USA.
authors.forename: Heidi
authors.initials: H
authors.lastname: Goldsmith
authors.affiliation: Aspire Bariatrics, Inc., King of Prussia, Pennsylvania, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: McCrea
authors.affiliation: Weill Cornell Medical College, New York, New York, USA.
authors.forename: Louis J
authors.initials: LJ
authors.lastname: Aronne
mesh_terms: D015746:Abdominal Pain / Q000453:epidemiology*; D000328:Adult; D004035:Diet Therapy; D004322:Drainage / Q000379:methods*; D005081:Exercise Therapy; D005260:Female; D005774:Gastrostomy / Q000379:methods*; D006097:Granulation Tissue; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D011183:Postoperative Complications / Q000453:epidemiology*; D016896:Treatment Outcome; D015431:Weight Loss