title: Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.
abstract: Evaluate safety and efficacy of the pose™ procedure for obesity treatment.
  
  
  
  Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events.
  
  
  
  Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068.
  
  
  
  The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.
authors.affiliation: Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Shelby
authors.initials: S
authors.lastname: Sullivan
authors.affiliation: HonorHealth Bariatric Center, Scottsdale, Arizona, USA.|Department of Surgery, University of Arizona School of Medicine, Scottsdale, Arizona, USA.
authors.forename: James M
authors.initials: JM
authors.lastname: Swain
authors.affiliation: Bariatric Surgery, Baptist Weight Loss Center, Memphis, Tennessee, USA.
authors.forename: George
authors.initials: G
authors.lastname: Woodman
authors.affiliation: Surgery, Lexington Medical Center, West Columbia, South Carolina, USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Antonetti
authors.affiliation: Laparoendoscopic and Bariatric Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
authors.forename: Nestor
authors.initials: N
authors.lastname: De La Cruz-Muñoz
authors.affiliation: Gastroenterology, St. Luke's Hospital of Kansas City (SLH), Saint Luke's GI Specialists, Kansas City, Missouri, USA.
authors.forename: Sreeni S
authors.initials: SS
authors.lastname: Jonnalagadda
authors.affiliation: Bariatric Surgery, NorthShore University Health System Evanston, Illinois, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Ujiki
authors.affiliation: Bariatric Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Sayeed
authors.initials: S
authors.lastname: Ikramuddin
authors.affiliation: Bariatrics, Chattanooga Bariatrics, Chattanooga, Tennessee, USA.|Hamilton Medical Center, Dalton, Georgia, USA.
authors.forename: Jaime
authors.initials: J
authors.lastname: Ponce
authors.affiliation: Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Marvin
authors.initials: M
authors.lastname: Ryou
authors.affiliation: HonorHealth Bariatric Center, Scottsdale, Arizona, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Reynoso
authors.affiliation: Gastroenterology, St. Luke's Hospital of Kansas City (SLH), Saint Luke's GI Specialists, Kansas City, Missouri, USA.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Chhabra
authors.affiliation: Bariatric Surgery, St. Luke's Hospital of Kansas City, Kansas City, Missouri, USA.
authors.forename: G Brent
authors.initials: GB
authors.lastname: Sorenson
authors.affiliation: Gastroenterology, University of Missouri Kansas City School of Medicine and St. Luke's Hospital of Kansas City, Kansas City, Missouri, USA.
authors.forename: Wendell K
authors.initials: WK
authors.lastname: Clarkston
authors.affiliation: Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Edmundowicz
authors.affiliation: Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: J Christopher
authors.initials: JC
authors.lastname: Eagon
authors.affiliation: Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Mullady
authors.affiliation: Bariatric Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Leslie
authors.affiliation: Surgery, Surgical Specialists of Louisiana, Metairie, Louisiana, USA.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Lavin
authors.affiliation: Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Thompson
mesh_terms: D000328:Adult; D050110:Bariatric Surgery; D004311:Double-Blind Method; D004724:Endoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D061214:Patient Safety; D016896:Treatment Outcome; D055815:Young Adult