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

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Device: intragastric Elipse Device

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Elipse capsule insertion group; All patient who inserted elipse capsule in single clinic

Device: intragastric Elipse Device; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss	weight loss	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms & its severity	nausea , vomiting, abdominal pain	4 months
patient satisfaction	overall patient satisfaction: patients were given a short questionnaire with a scale from (0 - 10) for each: ease of the procedure, symptoms and severity, satisfaction with the results, & the overall costs.	4 months
overall cost	overall cost spent for this procedure	4 months

Collaborators and Investigators

• Sponsor: Amiri Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: obesity
• Other Study ID Numbers: AmiriH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This is a study for publication in International surgical journal to be shared by all clinicians using this device

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No