NCT04820036Active, not recruiting
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG): Effects of ESG on Non-Alcoholic Steatohepatitis (NASH) and Portal Pressure Gradient in Patients With Obesity and NASH With Advanced Fibrosis
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Mar 2021
- Start date
- 6 May 2021
- Primary completion date
- 24 Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04820036
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 6 May 2021 to the primary completion date, 24 Dec 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.
Other illness
- Decompensated cirrhosis (defined as bleeding varices, ascites, encephalopathy and jaundice)
- active participation in any weight loss program, the use of a weight loss medication over the past 6 months and history of bariatric surgery or EBMT.
Lab values
- diabetes mellitus (defined as HbA1c ≥ 6.5%)
- being on an anticoagulant or anti-platelet medication
Other
- gastric varices
- active smoking
- Patients with esophageal varices are not excluded as long as they are on a non-selective beta-blocker for primary prophylaxis.
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
- Patient is unwilling or unable to sign and date the informed consent.
- Patient is unwilling or unable to comply with the follow-up study schedule.
- Patient for whom endoscopic procedures are contraindicated.
Who the study is looking for
- Patient is 18-65 years old
- Obesity (defined as BMI \> 30 kg/m2)
- Biopsy-proven NASH (defined as the presence of steatosis and hepatic injury in the form of ballooning or lobular inflammation)19
- Advanced fibrosis (defined as bridging fibrosis (F3) or cirrhosis (F4) on LB).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.