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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

COMPLETEDNA

Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

NCT01761370•National University Hospital, Singapore

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.

Eligibility

Age

21 - 65 years

Sex

ALL

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.

Locations (1)

National University Hospital

Singapore, Singapore

Key Dates

Start Date

November 1, 2005

Primary Completion Date

September 1, 2008

Completion Date

September 1, 2008

Last Updated

January 4, 2013

Enrollment

ACTUAL participants

Conditions

Non Alcoholic Steatohepatitis

Interventions

AHA diet plus exercise with BIB placement

PROCEDURE

AHA diet plus exercise with sham BIB placement

PROCEDURE

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TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Inclusion Criteria

Exclusion Criteria

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

A Phase 2b Study of Icosabutate in Fatty Liver Disease

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)