100 12 Month Randomized Sham Controlled Trial Evaluating the Safety and Efficacy of Targeted Use of Endoscopic Suture Anchors for Primary Obesity: The ESSENTIAL Study

Sullivan, Shelby; Swain, James; Woodman, George; Antonetti, Marc; Jonnalagadda, Sreeni; Ujiki, Michael; Ikramuddin, Sayeed; Ponce, Jaime; Ryou, Marvin; Reynoso, Jason F.; Chhabra, Rajiv; Sorenson, G. Brent; Clarkston, Wendell K.; Edmundowicz, Steven A.; Eagon, J. Christopher; Mullady, Dan; Leslie, Daniel B.; Thompson, Christopher C.; Lavin, Thomas

doi:10.1016/s0016-5085(16)30211-6

Cited by 12 publications

(8 citation statements)

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“…The 34 patients who participated in the lead-in open-label portion of the study achieved 7%±7.4% TBWL at 12 months. The rate of SAEs was 4.7% ([1.9% vomiting, 1.6% nausea, and 0.4% pain, all requiring longer hospitalization] as well as 0.4% extragastric bleeding requiring open surgery, and 0.4% liver abscess requiring percutaneous drainage) [ 48 , 49 ]. Lastly, POSE was associated with improved satiation and gut neuroendocrine reaction [ 47 ].…”

Section: Endoscopic Suturing or Plication Devicesmentioning

confidence: 99%

Recent Clinical Results of Endoscopic Bariatric Therapies as an Obesity Intervention

2017

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Despite advances in lifestyle interventions, anti-obesity medications, and metabolic surgery, the issue of health burden due to obesity continues to evolve. Interest in endoscopic bariatric techniques has increased over the years, as they have been shown to be efficacious, reversible, relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some patients who may otherwise be unable to undergo bariatric surgery. This article aims to review the literature on the safety and efficacy of currently offered endoscopic bariatric techniques, as well as those that are in the pipeline of end-development and regulatory approval.

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Section: Endoscopic Suturing or Plication Devicesmentioning

confidence: 99%

Recent Clinical Results of Endoscopic Bariatric Therapies as an Obesity Intervention

2017

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“…The rate of serious adverse events in this trial was 4.7%, which consisted primarily of postprocedural nausea, vomiting, and/or pain requiring a prolonged hospital stay. Notably, the mean procedure time in this study was 39.7 ± 12.9 minutes …”

Section: Gastric Restrictive Methodsmentioning

confidence: 98%

Endoluminal weight loss and metabolic therapies: current and future techniques

Hill

Khashab

Kalloo

et al. 2017

Annals of the New York Academy of Sciences

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Obesity is a public health epidemic associated with a number of comorbidities, most notably type 2 diabetes and hypertension, as well as elevated all-cause mortality. The treatment for obesity and its associated comorbidities has most recently expanded into the field of bariatric endoscopy. This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Because of its minimally invasive nature, bariatric endoscopic therapy has the potential to appeal to the large sector of the obese population that resists surgery, as well as those early in the onset of obesity. To date, five endoscopic devices have been approved by the U.S. Food and Drug Administration for the treatment of obesity, and many more are in development, undergoing clinical trials, or being used around the world. Here, we present the current state of the field, highlight recent developments, and describe the clinical outcomes of these minimally invasive procedures in terms of weight loss, improvement in metabolic profile, and reduction in comorbidities.

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“…The co-primary endpoint of the study, namely the achievement of a %TBWL greater than 5% in more than 50% of patients, was not reached, but improvement of glycemic control, hypertension, and cholesterol levels were reported in the POSE group. 58 Better results were achieved in a European multicenter study, which reported a %TBWL of 13% and a %EWL of 45% in the active group versus 5.3% and 18.1% in the lifestyle group, respectively. 59 Consistent results with this trial were previously published by two observational Spanish cohorts.…”

Section: Restrictive Proceduresmentioning

confidence: 96%

“…60,61 No SAEs were reported, except in the first trial, where one case of extra-gastric bleeding requiring surgical intervention and one case of hepatic abscess requiring interventional drainage were reported (overall SAEs rate of 4.7%). 58 A recent systematic review and meta-analysis by Gys and colleagues analyzed the efficacy and safety of ESG and POSE procedure. The authors concluded that pooled %EWL at 12 months was 68.3% for ESG and 44.9% for POSE procedure.…”

Section: Restrictive Proceduresmentioning

confidence: 99%

Procedures and devices for bariatric and metabolic endoscopy

Orlandini

Gallo

Boškoski

et al. 2020

Clin Med Insights Gastroenterol

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Obesity is a leading cause of preventable death in developed countries, with a rising incidence over time. Lifestyle modification, pharmacotherapy, and bariatric surgery are the mainstays of bariatric therapy, even though burdened by several limitations in terms of efficacy or safety. Bariatric endoscopy has been developed in the last decades as a minimally invasive alternative, aimed to bridge the gap between conservative and interventional conventional therapies. This review aims to provide an updated overview of the bariatric and metabolic available endoscopic procedures and to drive the choice of the right procedure for the right patient.

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100 12 Month Randomized Sham Controlled Trial Evaluating the Safety and Efficacy of Targeted Use of Endoscopic Suture Anchors for Primary Obesity: The ESSENTIAL Study

Cited by 12 publications

References 0 publications

Recent Clinical Results of Endoscopic Bariatric Therapies as an Obesity Intervention

Recent Clinical Results of Endoscopic Bariatric Therapies as an Obesity Intervention

Endoluminal weight loss and metabolic therapies: current and future techniques

Procedures and devices for bariatric and metabolic endoscopy

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