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

NCT04182646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-01

No results posted yet for this study

Summary

Aims and objectives:

The Investigator aimed to evaluate effect of adjustable intra gastric balloon on non-alcoholic fatty liver disease/non alcoholic steatohepatitis (NAFLD/NASH) with or without diabetes mellitus, who have failed to achieve \>10% of total body weight with lifestyle interventions and pharmacotherapy for weight loss.

The Investigator will evaluate NASH parameters such as NASH activity score(NAS), liver function tests along with weight loss and change in glycaemic control and changes in hormonal activity.

Sample size:

Based on previous study, to achieve median reduction of 40% in NAS score with 80% power and 0.05 as type 1 error; total sample size required is 36 cases.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Non-Alcoholic Steatohepatitis
  • Obesity
  • Diabetes 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

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Rakesh Kalapala, DNB · Asian Institute of Gastroenterology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2023-04-20
Completion
2023-10-04

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT04182646 on ClinicalTrials.gov