Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05507151

Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University

Morgantown, West Virginia, 26508, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
  • Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
  • Patients older than 18 years and younger than 75 years of age at the time of consent
  • Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
  • Patients willing and able to comply with study requirements for follow-up

Exclusion criteria

  • Patients who are treated with intragastric balloons
  • Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
  • Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
  • Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
  • Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
  • Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
  • Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
  • Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
  • Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
  • The patient refuses or is unable to provide written informed consent
  • Prior bariatric treatment procedure

Treatment and study plan

Endoscopic Sleeve Gastroplasty

Procedure

endoscopic suturing of the stomach

Primary outcomes

  1. Change in Controlled Attenuation Parameter of Steatosis

    Time frame: Baseline (Before ESG)

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

  2. Change in Controlled Attenuation Parameter of Steatosis

    Time frame: 6 months post ESG

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

  3. Change in Controlled Attenuation Parameter of Steatosis

    Time frame: 12 months post ESG

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

  4. Change in Liver Stiffness Measurement of Fibrosis

    Time frame: Baseline (Before ESG)

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

  5. Change in Liver Stiffness Measurement of Fibrosis

    Time frame: 6 months post ESG

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

  6. Change in Liver Stiffness Measurement of Fibrosis

    Time frame: 12 months post ESG

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

Secondary outcomes

  1. Anthropometric Evaluation

    Time frame: 6 months post ESG

    Changes in Anthropometric evaluation from baseline to 6 months post ESG

  2. BMI Changes

    Time frame: 6 months post ESG

    Compare the change in BMI from baseline to the 6 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet).

  3. BMI Changes

    Time frame: 12 months post ESG

    Compare the change in BMI from baseline to the 12 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet).

  4. Excess Weight Loss Changes

    Time frame: 6 months post ESG

    Percent excess weight loss change from baseline to 6 months

  5. Excess Weight Loss Changes

    Time frame: 12 months post ESG

    Percentage of excess weight loss change from baseline to 12 months

  6. Total Body Weight Loss Changes

    Time frame: 6 months post ESG

    Percentage of total body weight loss (TBWL) from baseline to 6 months

  7. Total Body Weight Loss Changes

    Time frame: 12 months post ESG

    Percentage of total body weight loss (TBWL) from baseline to 12 months

  8. Absolute Body Weight Loss Changes

    Time frame: 6 months post ESG

    Percentage of Absolute Body Weight Loss from baseline to 6 months

  9. Absolute Body Weight Loss Changes

    Time frame: 12 months post ESG

    Percentage of Absolute Body Weight Loss from baseline to 12 months

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.