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

April 23, 2026 updated by: Shailendra Singh, West Virginia University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26508
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Endoscopic Sleeve Gastroplasty
endoscopic suturing of the stomach
Procedure: Endoscopic Sleeve Gastroplasty
endoscopic suturing of the stomach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Before ESG)
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.
6 months post ESG
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.
12 months post ESG
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.
Baseline (Before ESG)
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 months post ESG
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.
12 months post ESG

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric Evaluation
Time Frame: 6 months post ESG
Changes in Anthropometric evaluation from baseline to 6 months post ESG
6 months post ESG
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).
6 months post ESG
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).
12 months post ESG
Excess Weight Loss Changes
Time Frame: 6 months post ESG
Percent excess weight loss change from baseline to 6 months
6 months post ESG
Excess Weight Loss Changes
Time Frame: 12 months post ESG
Percentage of excess weight loss change from baseline to 12 months
12 months post ESG
Total Body Weight Loss Changes
Time Frame: 6 months post ESG
Percentage of total body weight loss (TBWL) from baseline to 6 months
6 months post ESG
Total Body Weight Loss Changes
Time Frame: 12 months post ESG
Percentage of total body weight loss (TBWL) from baseline to 12 months
12 months post ESG
Absolute Body Weight Loss Changes
Time Frame: 6 months post ESG
Percentage of Absolute Body Weight Loss from baseline to 6 months
6 months post ESG
Absolute Body Weight Loss Changes
Time Frame: 12 months post ESG
Percentage of Absolute Body Weight Loss from baseline to 12 months
12 months post ESG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shailendra Singh, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2202523300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings