Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

National University Health System (NUHS)

Status

Completed

Conditions

Non Alcoholic Steatohepatitis

Treatments

Procedure: AHA diet plus exercise with BIB placement

Procedure: AHA diet plus exercise with sham BIB placement

Study type

Interventional

Funder types

Other

Identifiers

NCT01761370

D/05/338

Details and patient eligibility

About

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

Full 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.

Enrollment

21 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.