New stomach muscle cut aims to curb appetite and shed pounds
NCT ID NCT05711758
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Delayed gastric emptying following procedure are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?
- Can a cold cloth on the neck calm Post-Surgery nausea?