Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
1 other identifier
interventional
21
1 country
1
Brief Summary
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedJanuary 4, 2013
October 1, 2011
2.8 years
November 1, 2011
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in liver histology
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.
6 months
Study Arms (2)
Treatment
ACTIVE COMPARATORAHA diet plus exercise with BIB placement
Sham control
SHAM COMPARATORAHA diet plus exercise with sham BIB placement
Interventions
AHA diet plus exercise with BIB placement for 6 months
AHA diet plus exercise with sham BIB placement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, 119074, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yin Mei Lee, MBChB
National University Hospital, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
January 4, 2013
Study Start
November 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
January 4, 2013
Record last verified: 2011-10