Randomized sham‐controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial
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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.
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Two RCTs and 1 cohort study investigating the Pose® procedure reported excess weight loss between 16% and 45%.
“Two RCTs and 1 cohort study investigated the effect of the Pose® procedure and reported EWL between 16–45% [149–151].”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [150]
The safety profile of the Pose® procedure seems acceptable, but certainty in the evidence was very low.
“The procedure safety profile seems acceptable, however certainty in the evidence was very low.”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [150]
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- Authors
- Sullivan, S., Swain, J. M., Woodman, G., Antonetti, M., De La Cruz‐Muñoz, N., Jonnalagadda, S. S., Ujiki, M., Ikramuddin, S., Ponce, J., Ryou, M., Reynoso, J., Chhabra, R., Sorenson, G. B., Clarkston, W. K., Edmundowicz, S. A., Eagon, J. C., Mullady, D. K., Leslie, D., Lavin, T. E., & Thompson, C. C.
- Affiliations
- Washington University in St. Louis (US)
- University of Arizona (US)
- Bariatric Surgery Baptist Weight Loss Center Memphis Tennessee USA
- Lexington Medical Center (US)
- Laparoendoscopic and Bariatric Surgery University of Miami Miller School of Medicine Miami Florida USA
- Saint Luke's Hospital (US)
- Endeavor Health (US)
- University of Minnesota (US)
- Hamilton Medical Center (US)
- Brigham and Women's Hospital (US)
- HonorHealth (US)
- Bariatric Surgery St. Luke's Hospital of Kansas City Kansas City Missouri USA
- Surgery Surgical Specialists of Louisiana, Metairie Louisiana USA
- Corresponding author
- Sullivan, Shelby
- ORCID
- Venue
- Obesity
- Publisher
- Wiley
- Published
- 2016-12-21
- Volume
- 25
- Issue
- 2
- Pages
- 294-301
- ISSN
- 1930-7381 (ISSN-L)
- 1930-739X
- OpenAlex
- W2561849160
- Cited by
- 179
- References
- 21
- Citations by year
- 2026: 6 · 2025: 21 · 2024: 24 · 2023: 21 · 2022: 15 · 2021: 18 · 2020: 28 · 2019: 19 · 2018: 13 · 2017: 13 · 2016: 1
- FWCI
- 16.97
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Obesity (publishedVersion)
- PubMed (publishedVersion)
- Funders
- USGI Medical, Inc
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Keywords
- primary obesity, weight loss, bariatric endoscopy, procedural safety, adverse events, lifestyle therapy
- MeSH terms
- Adult, Double-Blind Method, Endoscopy, Female, Humans, Male, Middle Aged, Obesity, Morbid, Treatment Outcome, Bariatric Surgery, Young Adult, Patient Safety
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