Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03160469
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Saud AL-Subaie, Amiri Hospital

Tracking Information
First Submitted Date  ICMJE May 17, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date May 19, 2017
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
weight loss [ Time Frame: 4 months ]
weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • symptoms & its severity [ Time Frame: 4 months ]
    nausea , vomiting, abdominal pain
  • 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.
  • overall cost [ Time Frame: 4 months ]
    overall cost spent for this procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
Official Title  ICMJE Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Obese
Intervention  ICMJE 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".
Study Arms  ICMJE Experimental: Elipse capsule insertion group
All patient who inserted elipse capsule in single clinic
Intervention: Device: intragastric Elipse Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2017)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03160469
Other Study ID Numbers  ICMJE AmiriH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: This is a study for publication in International surgical journal to be shared by all clinicians using this device
Current Responsible Party Saud AL-Subaie, Amiri Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amiri Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Amiri Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP