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Stomach sleeve without surgery shows promise for fatty liver

NCT ID NCT04820036

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a non-surgical stomach reduction procedure (endoscopic sleeve gastroplasty) can improve liver health in people with obesity and advanced NASH (a severe form of fatty liver disease). Twenty adults with obesity and biopsy-confirmed NASH with advanced scarring will have the procedure and be followed for 12 months. Researchers will measure changes in liver function, scarring, and fat content using liver biopsies and imaging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). 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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endoscopic sleeve gastroplasty Endoscopic ultrasound Liver fibroses Liver function Non-alcoholic fatty liver disease (NAFLD) Non-alcoholic steatohepatitis (NASH) Obesity

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.