Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Condition: Obese
Study type: Interventional

Summary: 
      a prospective intragastric elipse balloon effect on weight loss for certain BMI. this study
      also proposed to assess the safety of the elipse balloon
    

Detailed description: 
      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.
    

Intervention name(s): intragastric Elipse Device
Intervention type(s): Device
Intervention description(s): 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".
Intervention model: Single Group Assignment
Intervention model description: 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. Ethical approval was obtained from the Ministry of Health in Kuwait & national ethics committee.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity