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Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02129296
Recruitment Status : Unknown
Verified April 2015 by MOHAMED ABDELLATIF, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, Mansoura University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Weight Loss Tolerance Device: Air filled balloon Device: Bioenteric BIB® balloon Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Study Start Date : September 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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 Name: 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 Name: second group




Primary Outcome Measures :
  1. Tolerance [ Time Frame: 6 months ]
    Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months ]
    Weight loss by Kg and BMI,

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Morbidly obese patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129296


Contacts
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Contact: mohamed e abd ellatif, PhD 0543973660

Locations
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Egypt
Hafr Albatin Central hospital Recruiting
Mansoura University, Egypt
Contact: mohamed e abd Ellatif, phd    0543973660      
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed E Abd Ellatif, PhD Mansoura University

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Responsible Party: MOHAMED ABDELLATIF, PhD, Mansoura University
ClinicalTrials.gov Identifier: NCT02129296     History of Changes
Other Study ID Numbers: Gastric balloon
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by MOHAMED ABDELLATIF, Mansoura University:
Morbid obesity
Gastric balloon
Weight loss
Tolerance
Safety

Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action