Back to resultsEffect of Gastric Balloon in Morbid Obesity: Prospective Study
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
BMI more than 45 BMI
BMI less than 45 BMI
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring gastric balloon, morbid obesity
Eligibility Criteria
Inclusion Criteria:
- morbid obesity
Exclusion Criteria:
- patient refusal
- psychological patients
- oesophageal or gastric abnormalities
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BMI more than 45 BMI
BMI less than 45 BMI
Arm Description
Air filled gastric balloon (Heliosphere) those BMI above 45
Air filled gastric balloon (Heliosphere)those BMI below 45
Outcomes
Primary Outcome Measures
Effect of weight loss
By following up the BMI every month
Secondary Outcome Measures
Tolerance
Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02128165
Brief Title
Effect of Gastric Balloon in Morbid Obesity: Prospective Study
Official Title
Effect of Gastric Balloon in Morbid Obesity: Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
gastric balloon, morbid obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMI more than 45 BMI
Arm Type
Active Comparator
Arm Description
Air filled gastric balloon (Heliosphere) those BMI above 45
Arm Title
BMI less than 45 BMI
Arm Type
Active Comparator
Arm Description
Air filled gastric balloon (Heliosphere)those BMI below 45
Intervention Type
Device
Intervention Name(s)
BMI more than 45 BMI
Intervention Description
Air filled gastric balloon (Heliosphere) those BMI above 45
Intervention Type
Device
Intervention Name(s)
BMI less than 45 BMI
Intervention Description
Air filled gastric balloon (Heliosphere) those BMI below 45
Primary Outcome Measure Information:
Title
Effect of weight loss
Description
By following up the BMI every month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tolerance
Description
Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
morbid obesity
Exclusion Criteria:
patient refusal
psychological patients
oesophageal or gastric abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed e abd ellatif, phd
Phone
0543973660
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed e abd Ellatif, phd
Phone
0543973660
12. IPD Sharing Statement
Learn more about this trial
Effect of Gastric Balloon in Morbid Obesity: Prospective Study
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