🏛️ Verified NIH Record • Updated 2025-11-25

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) (NCT04820036)

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

🔵 Active, Not Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Brigham and Women's Hospital

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (12 items).

Location: Brigham and Women's Hospital — Boston, Massachusetts

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

  • Insulin Resistance (DIAGNOSTIC_TEST)
  • Quality of Life Assessment (BEHAVIORAL)
  • Liver Function Test (DIAGNOSTIC_TEST)
  • Radiologic features of NASH (DIAGNOSTIC_TEST)
  • Serologic features of NASH (DIAGNOSTIC_TEST)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Decompensated cirrhosis (defined as bleeding varices, ascites, encephalopathy and jaundice)
  • gastric varices
  • diabetes mellitus (defined as HbA1c ≥ 6.5%)
  • active smoking
  • being on an anticoagulant or anti-platelet medication
  • 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.
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Brigham and Women's Hospital — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Non-alcoholic Steatohepatitis (NASH) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗