Effect of Gastric Balloon in Morbid Obesity: Prospective Study

April 7, 2015 updated by: MOHAMED ABDELLATIF, Mansoura University
The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.

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, Egypt
        • Recruiting
        • Mansoura University
        • 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:

  • morbid obesity

Exclusion Criteria:

  • patient refusal
  • psychological patients
  • oesophageal or gastric abnormalities

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BMI more than 45 BMI
Air filled gastric balloon (Heliosphere) those BMI above 45
Device: BMI more than 45 BMI
Air filled gastric balloon (Heliosphere) those BMI above 45
Active Comparator: BMI less than 45 BMI
Air filled gastric balloon (Heliosphere)those BMI below 45
Device: BMI less than 45 BMI
Air filled gastric balloon (Heliosphere) those BMI below 45

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of weight loss
Time Frame: 6 months
By following up the BMI every month
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance
Time Frame: 6 months
Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain
6 months

Collaborators and Investigators

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

Sponsor

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

August 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 26, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 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

  • Air 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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