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

Launched by CHRISTOPHER C. THOMPSON, MD, MSC · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new weight loss procedure called Pylorus Sparing Antral Myotomy (PSAM). The goal is to see how safe and effective PSAM is when used on its own, without any other procedures. PSAM is designed to help people with obesity by slowing down how quickly food leaves the stomach, which can lead to weight loss. Researchers want to understand how this procedure affects the body and if it can be a better option for patients looking to lose weight.

To participate in this study, you need to be between 18 and 70 years old, have a body mass index (BMI) greater than 35, and be eligible for weight loss procedures. You should also be in good mental health and able to attend follow-up visits. If you have certain medical conditions, like untreated infections or severe gastrointestinal issues, you may not qualify. If you join the trial, you can expect to have the PSAM procedure and then return for regular check-ups to monitor your progress and any effects of the treatment. This study could help pave the way for larger trials in the future, potentially benefiting more people struggling with obesity.

Gender

ALL

Eligibility criteria

• 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