Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity
Phase 2
- Conditions
- Morbid obesity
- Registration Number
- JPRN-UMIN000005521
- Lead Sponsor
- Division of Gastroenterology and Hepatology, University of Tsukuba Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1.Morbid obese subjects with severe heart and lung disorders. 2.Morbid obese subjects with esophageal hiatus hernia. 3.Morbid obese subjects with inflammatory disorders in the alimentary tracts. 4.Morbid obese subjects with bleeding tendency. 5.Morbid obese subjects during pregnancy and those nursing a baby. 6.Morbid obese subjects who cannnot understand the meaning of intragastric balloon therapy and continue the therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight reduction induced by intragastric balloon therapy
- Secondary Outcome Measures
Name Time Method Changes in body composition, metabolic function, oxidative stress markers, and hepatic steatosis