Study of Weight Loss Effect of the Sequential Balloons

Not Applicable

• Conditions: Weight Loss; Balloon
• Interventions: Device: Heliosphere bag (air filled balloon)

• Registration Number: NCT02136173
• Lead Sponsor: Mansoura University

Brief Summary

The effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.

Detailed Description

We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-12
• 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

• BMI > 45 and weight >120 Kg
• Patients refused to have bariatric surgery.

Exclusion Criteria

• Esophageal or gastric or duodenal lesions.
• Bleeding disorders.
• uncooperative patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sequential balloons	Heliosphere bag (air filled balloon)	effect of weight loss by applying sequential balloons

Primary Outcome Measures

Name	Time	Method
weight loss	12 months	study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt