Effect of Gastric Balloon in Morbid Obesity: Prospective Study

Phase 1

• Conditions: Morbid Obesity
• Interventions: Device: BMI less than 45 BMI; Device: BMI more than 45 BMI

• Registration Number: NCT02128165
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-04-26
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

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

Inclusion Criteria

• morbid obesity

Exclusion Criteria

• patient refusal
• psychological patients
• oesophageal or gastric abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI less than 45 BMI	BMI less than 45 BMI	Air filled gastric balloon (Heliosphere)those BMI below 45
BMI more than 45 BMI	BMI more than 45 BMI	Air filled gastric balloon (Heliosphere) those BMI above 45

Primary Outcome Measures

Name	Time	Method
Effect of weight loss	6 months	By following up the BMI every month

Secondary Outcome Measures

Name	Time	Method
Tolerance	6 months	Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt