Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

NCT ID: NCT02129296

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

PHASE1/PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-08-31

Brief Summary

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Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Detailed Description

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Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Conditions

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Morbid Obesity Weight Loss Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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hemiosphere® BALLOON

Balloon filled with air according to the manufacturing company orders 600 or 720 ml air

Group Type ACTIVE_COMPARATOR

Air filled balloon

Intervention Type DEVICE

Balloon filled with air according to the manufacturing company orders

Fluid filled balloon

Balloon filled with saline and methylene blue according to the manufacturing company orders

Group Type ACTIVE_COMPARATOR

Bioenteric BIB® balloon

Intervention Type DEVICE

Balloon filled with saline and methylene blue according to the manufacturing company orders

Interventions

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Air filled balloon

Balloon filled with air according to the manufacturing company orders

Intervention Type DEVICE

Bioenteric BIB® balloon

Balloon filled with saline and methylene blue according to the manufacturing company orders

Intervention Type DEVICE

Other Intervention Names

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first group second group

Eligibility Criteria

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Inclusion Criteria

* Morbidly obese patients

Exclusion Criteria

* Patient refused
* Non compliant patients
* Psychological patients
* Oesophageal varices, big hiatus hernia, ulcers
* Gastric vascular malformations
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

Principal Investigators

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Mohamed E Abd Ellatif, PhD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Hafr Albatin Central hospital

Mansoura University, , 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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Gastric balloon

Identifier Type: -

Identifier Source: org_study_id

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