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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

NCT01761370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-01-04

No results posted yet for this study

Summary

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

Conditions

  • Non Alcoholic Steatohepatitis

Interventions

PROCEDURE

AHA diet plus exercise with BIB placement

AHA diet plus exercise with BIB placement for 6 months

PROCEDURE

AHA diet plus exercise with sham BIB placement

AHA diet plus exercise with sham BIB placement

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Yin Mei Lee, MBChB · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761370 on ClinicalTrials.gov