Study of Weight Loss Effect of the Sequential Balloons

NCT ID: NCT02136173

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Weight Loss Balloon

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequential balloons

effect of weight loss by applying sequential balloons

Group Type EXPERIMENTAL

Heliosphere bag (air filled balloon)

Intervention Type DEVICE

sequential balloons . Heliosphere bag (air filled balloon)

Interventions

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Heliosphere bag (air filled balloon)

sequential balloons . Heliosphere bag (air filled balloon)

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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MOHAMED ABDELLATIF

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed e abd ellatif, PhD

Role: CONTACT

0543973660

Facility Contacts

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mohamed E abd Ellatif, phd

Role: primary

0543973660

Other Identifiers

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Sequential balloons

Identifier Type: -

Identifier Source: org_study_id

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