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

Abstract

The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

The current state of bariatric endoscopy

“…In the first multi‐center prospective study of 34 patients by the same authors, Elipse demonstrated a TBWL of 10% at 4‐month follow‐up with additional improvements in HbA 1c , triglycerides, low density lipoprotein, and blood pressure 59 . Two additional studies demonstrated 11.6% TBWL at 4 months though decreased %TBWL at 12 months of 5.9% 60,61 …”

A Randomized, Controlled Trial Comparing the Impact of a Low-Calorie Ketogenic vs a Standard Low-Calorie Diet on Fat-Free Mass in Patients Receiving an Elipse™ Intragastric Balloon Treatment

“…In accordance with other studies, the EIGB inclusion criteria were as follows: body mass index (BMI) ≥ 27 kg/m 2 , and less than 45 kg/m 2 , and age between 18 and 65 years. Exclusion criteria included previous bariatric or gastric surgery, bowel obstruction, hiatal hernia >5 cm, heart failure, blood coagulation disorders, more than one other abdominal/ gynecological operation, certified pregnancy, eating disorders (bulimia, binge eating disorder, or night eating syndrome) [1][2][3][4][5][6], serum creatinine level greater than 1.8 mg/ dL or liver enzyme (glutamic oxaloacetic transaminase (GOT) or glutamic pyruvic transaminase (GPT)) levels less than three times the upper limit of normal [17], inability to comply with the LCKD or LCD for religious reasons, or the presence of chewing or swallowing disorders. After EIGB placement, the patients were randomized into two groups: the LCKD group that followed a LCKD and the LCD group that followed a standard LCD.…”

“…Intragastric balloons have been used for weight loss (WL) in the last two decades, but the need for hospital recovery, upper GI endoscopy, and anesthesia is major limitations for this technique. The Elipse™ intragastric balloon (EIGB) is a new swallowable balloon that has no such limitations and has been proven to be safe, effective in achieving weight loss is also, and well tolerated by patients [1][2][3][4][5][6].…”

“…After EIGB placement, a standard low-calorie diet (LCD) program, based on a daily intake of about 1000-1200 kcal/ day, is generally prescribed [6]. The combination of the restrictive effect of EIGB and diet accounts for a significant loss of fatty free mass (FFM).…”

Reply to Letter to the Editor in Response to “Elipse Balloon: the Pitfalls of Excessive Simplicity”

“…However, since some IFSO nations do not specify the type of endoluminal procedures performed, we cannot rule out the possibility that the number of Elipse placed in 2016 is underestimated. To the best of our knowledge, some authors reported a small series of patients without any significant complication [2][3][4][5]. However, a recent multicenter, prospective study [6] enrolling a larger population of 135 patients described 1 SBO (0.74%) that required a laparoscopic enterotomy.…”