Skip to content

Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity

Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity - Intragastric balloon therapy for morbid obesity

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005521
Enrollment
12
Registered
2011-06-01
Start date
2011-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid obesity

Interventions

Intragastric balloon therapy

Sponsors

Division of Gastroenterology and Hepatology, University of Tsukuba Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Morbid obese subjects resistant to long-term (more than 6 months) medical treatments, such as diet, exercise, and behavior. 2.Morbid obese subjects in which the complications associted with obesity can be expected to improve by weight reduction. 3.Morbid obese subjects who can be followed up for at least 6 months after the start of intragastric balloon therapy. 4.Morbid obese subjects in which no abnormal lesions are found by upper alimentary tract endoscopy.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Weight reduction induced by intragastric balloon therapy

Secondary

MeasureTime frame
Changes in body composition, metabolic function, oxidative stress markers, and hepatic steatosis

Countries

Japan

Contacts

Public ContactJunichi Shoda

University of Tsukuba Hospital Gastroenterology and Hepatology

029-853-3900

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026