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Procedure

Endoscopic Sleeve Gastroplasty for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Pichamol Jirapinyo, MD, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is 18-65 years old
Advanced fibrosis (defined as bridging fibrosis (F3) or cirrhosis (F4) on LB).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 0, month 1, month 3, month 6, month 9, month 12
Awards & highlights

Study Summary

This trial will assess the effect of P-ESG on non-alcoholic fatty liver disease (NAFLD) by measuring changes in liver fat, inflammation, and fibrosis.

Who is the study for?
This trial is for adults aged 18-65 with obesity (BMI > 30) and advanced liver fibrosis or cirrhosis, who have biopsy-proven NASH. It's not for those with diabetes, gastric varices, decompensated cirrhosis, current smokers, or anyone on weight loss programs/medications recently.Check my eligibility
What is being tested?
The study investigates the impact of Endoscopic Sleeve Gastroplasty (ESG) on patients with Non-alcoholic Steatohepatitis (NASH). It will assess changes in liver function and structure through tests like blood work and imaging before and after ESG treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, ESG procedures may include risks such as pain at the procedure site, bleeding, infection risk from endoscopy, potential nutritional deficiencies due to altered digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My liver has advanced scarring.
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I have been diagnosed with NASH through a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 0, month 1, month 3, month 6, month 9, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, month 1, month 3, month 6, month 9, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Month 0 liver function at 12 months.
Secondary outcome measures
Change in Month 0 Anthropometric factors at months 1,3,6,9,12.
Change in Month 0 Quality of Life at 12 months.
Change in Month 0 insulin resistance at 6 and 12 months.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with Obesity and NASH scheduled/recommended for P-ESG ProcedureExperimental Treatment5 Interventions
We will perform a 12-month prospective, single-center, pilot observational study on patients with obesity and NASH with advanced fibrosis who are undergoing P-ESG. A total of 15 patients will undergo EUS-LB with EUS-PPG measurement in a single session prior to and at 12 months following P-ESG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality of Life Assessment
2009
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,213 Total Patients Enrolled
45 Trials studying Obesity
78,163 Patients Enrolled for Obesity
American Society for Gastrointestinal EndoscopyOTHER
27 Previous Clinical Trials
4,404 Total Patients Enrolled
1 Trials studying Obesity
8 Patients Enrolled for Obesity
Boston Scientific CorporationIndustry Sponsor
716 Previous Clinical Trials
934,493 Total Patients Enrolled
3 Trials studying Obesity
85 Patients Enrolled for Obesity

Media Library

P-ESG (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04820036 — N/A
Obesity Research Study Groups: Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure
Obesity Clinical Trial 2023: P-ESG Highlights & Side Effects. Trial Name: NCT04820036 — N/A
P-ESG (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04820036 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025