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Effect of Gastric Balloon in Morbid Obesity: Prospective Study

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ClinicalTrials.gov Identifier: NCT02128165
Recruitment Status : Unknown
Verified April 2015 by MOHAMED ABDELLATIF, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, Mansoura University

Brief Summary:
The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: BMI more than 45 BMI Device: BMI less than 45 BMI Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Gastric Balloon in Morbid Obesity: Prospective Study
Study Start Date : August 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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




Primary Outcome Measures :
  1. Effect of weight loss [ Time Frame: 6 months ]
    By following up the BMI every month


Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 6 months ]
    Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain



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

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • patient refusal
  • psychological patients
  • oesophageal or gastric abnormalities

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): NCT02128165


Contacts
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Contact: mohamed e abd ellatif, phd 0543973660

Locations
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Egypt
Mansoura University Recruiting
Mansoura, Egypt
Contact: mohamed e abd Ellatif, phd    0543973660      
Sponsors and Collaborators
Mansoura University

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Responsible Party: MOHAMED ABDELLATIF, phd, Mansoura University
ClinicalTrials.gov Identifier: NCT02128165     History of Changes
Other Study ID Numbers: Air gastric balloon
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by MOHAMED ABDELLATIF, Mansoura University:
gastric balloon
morbid obesity

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms