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

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests PSAM, a procedure that cuts part of the stomach muscle but leaves the stomach outlet intact, for weight loss. It studies PSAM alone to learn how safe it is, how well people tolerate it, and how it affects weight and stomach function in the short term. It is for adults ages 18–70 with a body mass index (BMI) over 35.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–70 years old.
  • You qualify for both weight loss surgery and weight loss procedures done with a scope.
  • Your BMI, a measure based on height and weight, is over 35.
  • You are in excellent mental health.
  • You can understand and sign a form agreeing to join the study.
  • You can return for all planned follow-up visits.

Who can't join

  • You have an untreated H. pylori stomach infection, slow stomach emptying, a blocked digestive tract, or long-term belly pain.
  • You have had digestive tract surgery, including surgery to cut or widen the stomach outlet.
  • You have inflammation in the digestive tract, such as severe irritation of the food pipe, active stomach or small intestine ulcers, or Crohn’s disease; or stomach cancer, a GIST tumor, or changes that may become cancer.
  • You have a serious blood-clotting problem, swollen veins in the food pipe or stomach, or stomach lining damage from high pressure in veins near the liver.
  • You have severe heart or lung disease, a history of disease in the heart’s arteries, a heart attack within 6 months, poorly controlled high blood pressure, required use of NSAID pain medicines, or another serious condition unrelated to weight that makes a scope procedure riskier.
  • You smoke, have used opioid pain medicines in the past 12 months, or take medicines that may affect weight loss or stomach emptying.
  • You are pregnant, recently gave birth, or are breastfeeding; or you have a hormone disorder affecting weight, such as an underactive thyroid that is not controlled.
  • You cannot give informed consent, have mental health issues that prevent joining a lifestyle-change program, or have another condition the study doctor believes could prevent you from following or finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA