NCT05711758 · Christopher C. Thompson, MD, MSc
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
(PSAM)
What this study is about
Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body.
View original scientific description
Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations