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

NCT03160469 | Completed DMC

• 1 other identifier: AmiriH
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obese

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• weight loss

  weight loss

  4 months

Secondary Outcomes (3)

• symptoms & its severity

  4 months

• patient satisfaction

  4 months

• overall cost

  4 months

Study Arms (1)

Elipse capsule insertion group

EXPERIMENTAL

All patient who inserted elipse capsule in single clinic

Device: intragastric Elipse Device

Interventions

intragastric Elipse Device 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".

Elipse capsule insertion group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amiri Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD , Specialist surgeon

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: July 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: April 30, 2017
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share