Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

This article was originally published electronically on the publisher's internet portal on May 5, 2020 without open access.

Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

An author name was incorrectly indicated in the Conflict of Interest Statement.

The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

PURPOSE: The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. MATERIALS AND METHODS: Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. RESULTS: Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). CONCLUSION: The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.

Improving Nausea and Vomiting Post-Elipse Balloon: a Novel Single-Dose Regimen of 300 mg Netupitant/0.5 mg Palonosetron Hydrochloride.

BACKGROUND: Post intragastric balloon placement symptoms like nausea and vomiting have been the major cause of a high rate of early removal. Common therapy with ondansetron alone, or in combination, with prokinetic agents have been shown to have very little or no effect. Recently, an improved therapy based on aprepitant and ondansetron combination showed a significant improvement in symptoms management. Lack of aprepitant availability in several countries and patients difficulties to follow the right prescription convinced us to explore other pharmacological options. OBJECTIVE: Evaluate safety and efficacy of a netupitant and palonosetron-combined drug and to reduce and control post Elipse® placement symptoms METHODS: Between January and March 2018, 30 patients (9 male, 21 female), (mean weight 97.8 and mean BMI 34.7), underwent Elispe® placements, at 550 ml volume, in an outpatient fashion. All patients received a single pill 300 mg netupitant/0.5 mg palonosetron 6 h prior to placement. All patients received ondansetron 4 mg prescription to be taken as needed. A daily VAS score to report intensity of nausea, vomit, cramps, gastric pain, satiety for the first week post-placement was completed. RESULTS: 4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3. CONCLUSION: In our experience, the use of a single-pill netupitant/palonosetron resulted to be very easy to administer and effective in reducing vomit, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Elipse™ placements symptoms safely.

Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience.

PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy. MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy. RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed. CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.