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New stomach muscle cut aims to curb appetite and shed pounds

NCT ID NCT05711758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests a new procedure called PSAM (Pylorus-Sparing Antral Myotomy) for weight loss in 30 adults with obesity. The procedure involves cutting some stomach muscles to slow down how fast food leaves the stomach, which may help people feel full longer and lose weight. Researchers are checking if it is safe, tolerable, and effective on its own, without combining it with other weight-loss procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pylorus-Sparing Antral Myotomy (PSAM) procedure
What this could lead to
If successful, PSAM could offer a new, less invasive weight-loss option for people with obesity, potentially reducing procedure time and risks compared to current methods.
What could go wrong
This is a very small pilot study with only 30 people, so results may not apply to everyone. The procedure is new and its long-term safety and effectiveness are unknown.

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.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

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.

Who is studied

Adults in the Center for Weight Management and Wellness program at Brigham and Women's Hospital with a BMI \>35 kg/m2 who are pre-qualified by their insurance as recommended by their specialist to undergo an endoscopic bariatric procedure.

Ages

18 to 70 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: * subjects must be 18-70 years of age * eligible for endoscopic and surgical weight loss procedures * body mass index (BMI) greater than 35 kg/m2 * Individuals must be in excellent mental health * able to understand and sign informed consent * available to return for all routine follow-up study visits Exclusion Criteria: * untreated H. pylori infection * gastroparesis * active smoking * an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment * previous pyloromyotomy or pyloroplasty * gastrointestinal obstruction * severe coagulopathy * esophageal or gastric varices and/or portal hypertensive gastropathy * pregnancy or puerperium * any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease) * malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST) * severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs) * lactation * history of gastrointestinal surgery * any serious health condition unrelated to their weight that would increase the risk of endoscopy * chronic abdominal pain * active psychological issues preventing participation in a lifestyle modification program * a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) * an inability to provide informed consent * use of any medication that may interfere with weight loss * use of any medication that may interfere with gastric emptying * any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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