Effect of Gastric Balloon in Morbid Obesity: Prospective Study

Mansoura University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Morbid Obesity

Treatments: Device: BMI more than 45 BMI; Device: BMI less than 45 BMI

Study type: Interventional

Funder types: Other

Identifiers

NCT02128165

Air gastric balloon

Details and patient eligibility

About

The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

Full description

To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• morbid obesity

Exclusion criteria

• patient refusal
• psychological patients
• oesophageal or gastric abnormalities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

BMI more than 45 BMI

Active Comparator group

Description:

Air filled gastric balloon (Heliosphere) those BMI above 45

Treatment:

Device: BMI more than 45 BMI

BMI less than 45 BMI

Active Comparator group

Description:

Air filled gastric balloon (Heliosphere)those BMI below 45

Treatment:

Device: BMI less than 45 BMI