Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
a prospective intragastric elipse balloon effect on weight loss for certain BMI. this study
 also proposed to assess the safety of the elipse balloon
Obesity prevalence is increasing worldwide, and Kuwait is currently considered to be the
 country with the most obese population1. Accordingly, standardization of the weight loss
 procedures has been made according to the Body Mass Index (BMI), keeping the more advanced
 surgeries for class II obesity (BMI 35- 39.9) and above, with consideration of other factors
 like, for example, obesity-related comorbidities. For those patients whom considered in the
 category of overweight (BMI = 25- 29.9) & class I obesity (BMI 30- 34.9), after failure of
 diet attempts, the weight loss options are limited. Of the highly requested options are the
 various types of intra-gastric balloons. Conventional endoscopic gastric balloons have proven
 to be safe and effective, with Excess Weight Loss (%EWL) of 25-50%2. A new swallowable
 gastric balloon, named Elipse, has been launched recently in Kuwait and became highly popular
 due to its unique concept of being "procedure-less".

 Elipse is a weight loss device that does not require anesthesia, endoscopy, or surgery in its
 "way in" or "way out". It's designed to be a swallowable capsule that is converted to a
 balloon in the stomach after filling it with a PH-titrated fluid through its connected
 catheter. It works by restricting the stomach and, as a result, weight loss is achieved by
 decreasing the overall food quantity intake. Four months later, part of the balloon patch
 side is shed-off and the fluid is expelled in the stomach in a gradual manner. Later, the
 fluid and the thin paper-like wall of the balloon pass through the gastrointestinal tract
 until excreted.

 This prospective study aims to observe the efficacy & safety of the procedure-less
 intra-gastric Elipse balloon as a tool aiding in weight loss applied to all patients in our
 clinic who fulfill the criteria & underwent insertion procedure by one surgeon. In this paper
 we share our experience regarding this new type of balloon, since Kuwait is one of the first
 countries to start official practice with this new device and data in literature is still
 lacking.

 This is a prospective pilot study of 48 patients underwent Elipse balloon insertion by the
 same surgeon at Faisal polyclinics in Kuwait city during six months period from July 2016 to
 January 2017. After insertion, the patients were followed for a period of four months until
 the expected day of excretion. Weight, BMI, & waist circumference were calculated once
 pre-insertion and at 1,2, and 4 months post-insertion in the clinic. Patients were also
 encouraged to send their body composition data through email using electronic scale at home
 in weekly basis. All the data regarding any difficulties or adverse events during the
 procedure were recorded. At the last visit, a simple questionnaire was handed to the patients
 to address the commitment to peri and post procedural instructions, symptoms & their severity
 encountered after insertion and excretion, overall costs spent, and patient satisfaction.
 Ethical approval was obtained from the Ministry of Health in Kuwait & national ethics
 committee.
Inclusion Criteria:

 all patients underwent elipse insertion from July 2016 to January 2017with:

 -  BMI 27-40

 -  Age 18-65

 -  Failed multiple diet attemps

 -  Motivated with realistic weight loss expectations, ready and committed to follow a
 physician-guided weight-loss program.

 Exclusion Criteria:

 -  Patients with psychologically-driven eating disorders (e.g. binge eating, bulimia,
 etc.)

 -  Patients with a history of abdominal and/or pelvic surgery EXCLUDING only ONE of the
 following surgeries that was performed at least 12 months prior to the Elipse™
 Treatment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy,
 laparoscopic cholecystectomy.

 -  Patient has had previous bariatric or gastric surgery.

 -  Patient has a history of acute pancreatitis.

 -  Patient has a history of small bowel obstructions.

 -  Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal
 disease including but not limited to hiatal hernias >2 centimeter (cm), inflammatory
 diseases, cancer, and varices.

 -  Patients with an abnormal swallowing mechanism.

 -  Patients with a history of cancer, inflammatory disease, bleeding or other disorder of
 the gastrointestinal (GI) tract.

 -  Women who are pregnant or breast feeding.