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Observational Study of Endoscopic Antral Myotomy for Weight Loss

This study is looking at a new procedure called Pylorus-Sparing Antral Myotomy (PSAM) as a way to help people lose weight. PSAM is a procedure done through an endoscope (a thin, flexible tube with a camera) while you are under general anesthesia. It works by changing how your stomach empties, which can help you feel full longer. Researchers want to see how much weight people lose with PSAM alone, and if it's a safe and well-tolerated procedure. You might be able to join if you are 18-70 years old, have a Body Mass Index (BMI) over 35 kg/m2, and are in good mental health. The study aims to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an observational study with 30 planned participants. It will look at the effects of the PSAM procedure.
What's involved
You would have the PSAM procedure and then attend follow-up visits at 1, 3, 6, 9, and 12 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the procedure to track weight changes, side effects, and how well the procedure is tolerated.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05711758

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure

Recruiting
Not specifiedAges 18–70Observational
Christopher C. Thompson, MD, MSc
~30 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:PSAM Treatment Patients

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight change compared to baseline
Measured over Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months
+2 more outcomes measured

Conditions

Obesity
Obesity, Morbid
Obesity, Primary
Metabolic Disease
Delayed Gastric Emptying Following Procedure

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christopher C. Thompson, MD, MSc · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Michele B. Ryan, MS
[email protected]
6176765928
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Weight change compared to baselineScreening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months

    Percent total body weight loss

  • Adverse EventsProcedure day, 1 month, 3 month, 6 month, 9 month, 12 months

    Changes to health compared to baseline

  • Change in tolerability from procedure day to 12 monthsProcedure day, 1 month, 3 month, 6 month, 9 month, 12 months

    How the subjects feel after the procedure based on pain scale and AE's