Trials / Unknown
UnknownNCT02129296
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Air filled balloon | Balloon filled with air according to the manufacturing company orders |
| DEVICE | Bioenteric BIB® balloon | Balloon filled with saline and methylene blue according to the manufacturing company orders |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2014-05-02
- Last updated
- 2015-04-08
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT02129296. Inclusion in this directory is not an endorsement.