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History of Changes for Study: NCT03160469
Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Latest version (submitted May 18, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 18, 2017 None (earliest Version on record)
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Study NCT03160469
Submitted Date:  May 18, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: AmiriH
Brief Title: Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Official Title: Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Completed
Study Start: July 1, 2016
Primary Completion: January 31, 2017 [Actual]
Study Completion: April 30, 2017 [Actual]
First Submitted: May 17, 2017
First Submitted that
Met QC Criteria:
May 18, 2017
First Posted: May 19, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
May 18, 2017
Last Update Posted: May 19, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Amiri Hospital
Responsible Party: Principal Investigator
Investigator: Saud AL-Subaie
Official Title: MD , Specialist surgeon
Affiliation: Amiri Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Obese
Keywords: obesity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
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.
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 50 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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".
Open or close this module Outcome Measures
Primary Outcome Measures:
1. weight loss
[ Time Frame: 4 months ]

weight loss
Secondary Outcome Measures:
1. symptoms & its severity
[ Time Frame: 4 months ]

nausea , vomiting, abdominal pain
2. patient satisfaction
[ Time Frame: 4 months ]

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.

3. overall cost
[ Time Frame: 4 months ]

overall cost spent for this procedure
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
This is a study for publication in International surgical journal to be shared by all clinicians using this device
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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