Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04820036 · ClinicalTrials.gov registry record · NA

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

A NA study of Obesity and Non-alcoholic Steatohepatitis (NASH), sponsored by Brigham and Women's Hospital.

Active
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT04820036: Active NA study of Obesity and Non-alcoholic Steatohepatitis (NASH), sponsored by Brigham and Women's Hospital.

NCT04820036 is a NA study of Obesity and Non-alcoholic Steatohepatitis (NASH) that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04820036, a NA study of Obesity and Non-alcoholic Steatohepatitis (NASH), is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

EUS-guided liver biopsy with portal pressure gradient measurement

Conditions Studied

Obesity Non-alcoholic Steatohepatitis (NASH) Non-Alcoholic Fatty Liver Disease (NAFLD) Endoscopic Sleeve Gastroplasty Liver Fibroses Liver Function Endoscopic Ultrasound

Interventions

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

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-05-06
Est. Completion 2027-12-24
Phase NA
Brigham and Women's Hospital

937 total trials

What the registry record for NCT04820036 still lists

NCT04820036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower).

The record links to 7 conditions, with Obesity appearing as the primary indexed condition, and to 5 interventions - of which Insulin Resistance is the first listed.

NCT04820036 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04820036 about?

NCT04820036 is a clinical study titled "A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)". 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-al...

What is the current status of trial NCT04820036?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-05-06. Estimated completion is 2027-12-24.

What conditions does trial NCT04820036 study?

This clinical trial studies the following conditions: Obesity, Non-alcoholic Steatohepatitis (NASH), Non-Alcoholic Fatty Liver Disease (NAFLD), Endoscopic Sleeve Gastroplasty, Liver Fibroses.

What interventions are being tested in trial NCT04820036?

The interventions under investigation include: 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).

Who is sponsoring clinical trial NCT04820036?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04820036 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04820036's enrollment target sits among peer trials

20 946th of 1053 higher than 80 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00573339 · 20 participants

    Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

  • NCT00692939 · 20 participants · Phase 1

    Autologous Stem Cell Transplantation for Crohn's Disease

  • NCT00967785 · 20 participants · Phase 1

    A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

  • NCT01406691 · 20 participants · Phase 4

    Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT04820036, the US trial registry maintained by the National Library of Medicine. NCT04820036 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.