Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-25 @ 3:40 AM
Study NCT ID:
NCT03160469
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Sponsor:
Amiri Hospital
Organization:
Study Overview
Official Title:
Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: