Non Alcoholic Steatohepatitis Clinical Trial
Official title:
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients between 21-65 years of age, - Had histological evidence of NASH, - Had a BMI of greater than 27kg/m2, and - Had failed at least 6 month trial of medical therapy for weight reduction. Exclusion Criteria: - Patients with any organic disease of the upper GI tract, - Were receiving anti-inflammatory drugs, - Anticoagulants or steroids, or - Had a history of alcoholism or drug addiction. A hiatus hernia of > 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in liver histology | The primary outcome measure was liver histology before and after treatment. Assessment of disease activity was done with the use of the NAS, which grades steatosis, lobular inflammation and hepatocellular ballooning. | 6 months | No |
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