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NCT02136173 Clinical Trial

Study of Weight Loss Effect of the Sequential Balloons

Weight Loss Clinical Trial

Official title:
Study of Weight Loss Effect of the Sequential Balloons

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02136173
Other study ID # Sequential balloons
Secondary ID
Status Recruiting
Phase N/A
First received May 7, 2014
Last updated April 7, 2015
Start date December 2012
Est. completion date December 2016

Study information
Verified date April 2015
Source Mansoura University
Contact mohamed e abd ellatif, PhD
Phone 0543973660
Is FDA regulated No
Health authority Saudi Arabia: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Heliosphere bag (air filled balloon)
sequential balloons . Heliosphere bag (air filled balloon)

Locations
Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight loss study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after 12 months Yes
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