Study of Weight Loss Effect of the Sequential Balloons

Mansoura University

Status: Unknown

Conditions: Weight Loss; Balloon

Treatments: Device: Heliosphere bag (air filled balloon)

Study type: Interventional

Funder types: Other

Identifiers

NCT02136173

Sequential balloons

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

sequential balloons

Experimental group

Description:

effect of weight loss by applying sequential balloons

Treatment:

Device: Heliosphere bag (air filled balloon)