Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

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).

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.

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.