Evzen Machytka

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.

Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up

BACKGROUND Obesity is the pandemic disease of this century. Surgery is the only effective treatment but cannot be offered to every patient. Endoscopic sutured gastroplasty is a minimally invasive technique that may potentially fill the gap between surgery and behavioral therapy. In this study, we prospectively investigated the efficacy and safety of a novel suturing device. METHODS After a pre-bariatric multidisciplinary work-up, class 1 and 2 obese patients were included. Using a simple triangulation platform, transmural sutures with serosa-to-serosa apposition were performed in the gastric cavity. Patients were followed according to the same routines as those performed for bariatric procedures. RESULTS Between November 2015 and December 2016, 51 patients were included across three European Centers. Mean body mass index at baseline was 35.1 kg/m2 (SD 3.0). Excess weight loss and total body weight loss at 1 year were 29 % (SD 28) and 7.4 % (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88 % of sutures were still in place (30 patients). No severe adverse events were observed. CONCLUSIONS Endoscopic sutured gastroplasty using this novel device is safe and achieved weight loss results in line with criteria expected for these endoluminal techniques. Further prospective studies vs. placebo or nutritional support are needed.

Short-term outcomes of the new intragastric balloon End-Ball® for treatment of obesity

Introduction Intragastric balloons (IGBs) have been successfully used to treat obesity for the last 18 years. These balloons are made of different materials and filled with either air or saline. It seems that balloons filled with saline result in more effective weight loss, but are associated with worse tolerance after implantation. In contrast, balloons filled with air are associated with excellent tolerance, but result in less effective weight loss. Aim To report the early safety and effectiveness results of the End-Ball® balloon and to encourage discussions on how to best use this new-generation IGB for endoscopic weight loss management. Material and methods Twenty obese patients (mean age: 40.5 years; mean body mass index: 34.8 kg/m2) were included in a 6-month study. Balloons were inflated with 300 ml of saline containing 5 ml of methylene blue and 300 cm3 of air. Results No serious adverse events occurred during treatment. Patients experienced varying degrees of nausea, vomiting (mean: 3.7 times the first day), and abdominal pain after implantation. Six months (23–29 weeks) after End-Ball® balloon insertion, we observed a significant decrease in body weight (13.9 ±5.1 kg) and percent excess weight loss (37.9 ±12.9%). We also found a significant decrease in the levels of glycated hemoglobin (p < 0.001), C-peptide (p < 0.002), and triacylglycerols (p < 0.001) and an increase in the concentration of high-density lipoprotein cholesterol (p < 0.025). Conclusions The End-Ball® IGB is a safe and effective treatment for morbid obesity, with positive effects on weight loss and saccharide metabolism.