Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

April 7, 2015 updated by: MOHAMED ABDELLATIF, Mansoura University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura University, Egypt
        • Recruiting
        • Hafr Albatin Central hospital
        • Contact:
          • mohamed e abd Ellatif, phd
          • Phone Number: 0543973660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Morbidly obese patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hemiosphere® BALLOON
Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
Device: Air filled balloon
Balloon filled with air according to the manufacturing company orders
Other Names:
  • first group
Active Comparator: Fluid filled balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
Device: Bioenteric BIB® balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
Other Names:
  • second group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance
Time Frame: 6 months
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 6 months
Weight loss by Kg and BMI,
6 months
Rate of deflation or puncture
Time Frame: 6 MONTHS
Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: mohamed e abd ellatif, phd, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

April 26, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastric balloon

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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