Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Mansoura University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Weight Loss; Tolerance; Morbid Obesity

Treatments: Device: Bioenteric BIB® balloon; Device: Air filled balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02129296

Gastric balloon

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Morbidly obese patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

hemiosphere® BALLOON

Active Comparator group

Description:

Balloon filled with air according to the manufacturing company orders 600 or 720 ml air

Treatment:

Device: Air filled balloon

Fluid filled balloon

Active Comparator group

Description:

Balloon filled with saline and methylene blue according to the manufacturing company orders

Treatment:

Device: Bioenteric BIB® balloon