Randomized Sham-Controlled Trial Evaluating Efficacy And Safety Of Endoscopic Gastric Plication For Primary Obesity: The Essential Trial

Objective: Evaluate safety and efficacy of the pose TM 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 5 111); 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.