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Randomized sham‐controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial
Author(s) -
Sullivan Shelby,
Swain James M.,
Woodman George,
Antonetti Marc,
De La CruzMuñoz 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.
Publication year - 2017
Publication title -
obesity
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.438
H-Index - 199
eISSN - 1930-739X
pISSN - 1930-7381
DOI - 10.1002/oby.21702
Subject(s) - medicine , adverse effect , randomized controlled trial , clinical endpoint , weight loss , incidence (geometry) , lead (geology) , obesity , surgery , physics , geomorphology , optics , geology
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.