Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Phase 1

• Conditions: Tolerance; Morbid Obesity; Weight Loss
• Interventions: Device: Air filled balloon; Device: Bioenteric BIB® balloon

• Registration Number: NCT02129296
• Lead Sponsor: Mansoura University

Brief Summary

Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Detailed Description

Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-26
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Morbidly obese patients

Exclusion Criteria

• Patient refused
• Non compliant patients
• Psychological patients
• Oesophageal varices, big hiatus hernia, ulcers
• Gastric vascular malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hemiosphere® BALLOON	Air filled balloon	Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
Fluid filled balloon	Bioenteric BIB® balloon	Balloon filled with saline and methylene blue according to the manufacturing company orders

Primary Outcome Measures

Name	Time	Method
Tolerance	6 months	Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia

Secondary Outcome Measures

Name	Time	Method
Rate of deflation or puncture	6 MONTHS	Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine
Weight loss	6 months	Weight loss by Kg and BMI,

Trial Locations

Locations (1)

Hafr Albatin Central hospital; 🇪🇬 Mansoura University, Egypt