NCT01761370

Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

Detailed description

The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.

Conditions

• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
PROCEDURE	AHA diet plus exercise with BIB placement	AHA diet plus exercise with BIB placement for 6 months
PROCEDURE	AHA diet plus exercise with sham BIB placement	AHA diet plus exercise with sham BIB placement

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2013-01-04
• Last updated: 2013-01-04

Locations

1 site across 1 country: Singapore