NCT05507151Active, not recruiting
Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis
Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 16 Aug 2022
- Start date
- 24 Aug 2022
- Primary completion date
- 31 May 2026
- Lead sponsor
- West Virginia University
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05507151
What you commit to
- Study type: Observational
- Planned participants: 30
- From 24 Aug 2022 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are treated with intragastric balloons
- 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.
- Prior bariatric treatment procedure
Other illness
- Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
- Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
- 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
Other
- Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
- The patient refuses or is unable to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.