Back to resultsStudy of Weight Loss Effect of the Sequential Balloons
Primary Purpose
Weight Loss, Balloon
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Heliosphere bag (air filled balloon)
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- BMI > 45 and weight >120 Kg
- Patients refused to have bariatric surgery.
Exclusion Criteria:
- Esophageal or gastric or duodenal lesions.
- Bleeding disorders.
- uncooperative patients.
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sequential balloons
Arm Description
effect of weight loss by applying sequential balloons
Outcomes
Primary Outcome Measures
weight loss
study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02136173
Brief Title
Study of Weight Loss Effect of the Sequential Balloons
Official Title
Study of Weight Loss Effect of the Sequential Balloons
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (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 effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.
Detailed Description
We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sequential balloons
Arm Type
Experimental
Arm Description
effect of weight loss by applying sequential balloons
Intervention Type
Device
Intervention Name(s)
Heliosphere bag (air filled balloon)
Intervention Description
sequential balloons . Heliosphere bag (air filled balloon)
Primary Outcome Measure Information:
Title
weight loss
Description
study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI > 45 and weight >120 Kg
Patients refused to have bariatric surgery.
Exclusion Criteria:
Esophageal or gastric or duodenal lesions.
Bleeding disorders.
uncooperative patients.
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
Study of Weight Loss Effect of the Sequential Balloons
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