Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01761370

Enrollment

Registered

2013-01-04

Start date

2005-11-30

Completion date

2008-09-30

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Steatohepatitis

Keywords

Non alcoholic Steatohepatitis, Intra-gastric balloon

Brief 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.

Interventions

PROCEDUREAHA diet plus exercise with BIB placement

AHA diet plus exercise with BIB placement for 6 months

PROCEDUREAHA diet plus exercise with sham BIB placement

AHA diet plus exercise with sham BIB placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in liver histology	6 months	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.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026