Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.

Sullivan, Shelby; Swain, James M; Woodman, George; Antonetti, Marc; De La Cruz-Muñoz, Nestor; Jonnalagadda, Sreeni S; Ujiki, Michael; Ikramuddin, Sayeed; Ponce, Jaime; Ryou, Marvin; Reynoso, Jason; Chhabra, Rajiv; Sorenson, G Brent; Clarkston, Wendell K; Edmundowicz, Steven A; Eagon, J Christopher; Mullady, Daniel K; Leslie, Daniel; Lavin, Thomas E; Thompson, Christopher C

OBJECTIVE Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS 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. RESULTS 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. CONCLUSIONS The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.