Effect of Adjustable Intragastric Balloon in Obese Non-alcoholic Fatty Liver Disease

NACompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 25, 2022

Primary Completion Date

April 20, 2023

Study Completion Date

October 4, 2023

Conditions
Non-Alcoholic Fatty Liver DiseaseNon-Alcoholic SteatohepatitisObesityDiabetes Mellitus, Type 2
Interventions
DEVICE

Spartz Balloon

The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing weight loss effect. The concept of an adjustable balloon came from the fact that around 10% of patients are intolerant to the balloon, requiring early extraction and also gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted. AIGB balloon can mitigate this effect by adjustment of balloon volumes as required

Trial Locations (1)

500082

Asian Institute of Gastroenterology Hospital, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER