Actively Recruiting

Age: 18Years - 70Years
All Genders
ID05711758

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

Led by Christopher C. Thompson, MD, MSc · Updated on 2026-03-02

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obesity, characterized by a body mass index (BMI) over 30 kg/m2, is a growing global health concern affecting a significant portion of the adult population. This research investigates a novel endoscopic weight loss procedure called Pylorus Sparing Antral Myotomy (PSAM), which aims to delay gastric emptying to promote weight loss. PSAM has previously been combined with endoscopic sleeve gastroplasty (ESG), showing promising results, but this study evaluates PSAM alone to understand its safety, tolerability, and short-term effectiveness. PSAM involves an endoscopic procedure performed under general anesthesia where a myotomy is created in the antral region of the stomach while preserving the pylorus. The technique uses submucosal endoscopy principles similar to gastric per-oral endoscopic myotomy (G-POEM). Patients receive PSAM with standard lifestyle modification therapy. The study includes three groups based on prior endoscopic bariatric therapy status: no prior therapy, prior primary therapy, and prior revision therapy. Participants will have assessments at screening, procedure day, and multiple follow-up points up to 12 months. Evaluations include weight change, adverse events, tolerability, quality of life, gastric emptying, hormone levels, glucose metabolism, and gastric motility. The study continuously monitors safety and physiological changes to provide comprehensive data on the procedure's impact, informing the design of larger future trials.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be 18 to 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
Not Eligible

You will not qualify if you...

  • Untreated Helicobacter pylori infection
  • Gastroparesis
  • Active smoking
  • Ongoing or history of opioid treatment in the last 12 months
  • Previous pyloromyotomy or pyloroplasty
  • Gastrointestinal obstruction
  • Severe coagulopathy
  • Esophageal or gastric varices and/or portal hypertensive gastropathy
  • Pregnancy or puerperium
  • Any inflammatory gastrointestinal disease (including severe esophagitis, active gastric or duodenal ulcers, Crohn's disease)
  • Malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
  • Severe cardiopulmonary disease or recent coronary artery disease
  • Lactation
  • History of gastrointestinal surgery
  • Serious health conditions unrelated to weight increasing endoscopy risk
  • Chronic abdominal pain
  • Active psychological issues preventing lifestyle modification participation
  • Known endocrine disorders affecting weight (uncontrolled hypothyroidism)
  • Inability to provide informed consent
  • Use of medications interfering with weight loss or gastric emptying
  • Any condition deemed by the investigator as a barrier to study compliance or completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure day

Participants undergo the pylorus-sparing antral myotomy (PSAM) procedure performed under general anesthesia. This involves an endoscopic myotomy using submucosal endoscopy techniques, with closure of the mucosal entry by endoscopic suturing or clips.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 12 months

Participants are followed to assess weight change, adverse events, tolerability, quality of life, and various physiological parameters related to gastric function.

Follow-up visits at 1 month, 3 months, 6 months, 9 months, and 12 months

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Michele B. Ryan, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means.

M L Klem, R R Wing, C C Chang...

https://pubmed.ncbi.nlm.nih.gov/10849578

Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity.

Barham K Abu Dayyeh, Elizabeth Rajan, Christopher J Gostout

https://pubmed.ncbi.nlm.nih.gov/23711556

Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study.

Victoria Gómez, George Woodman, Barham K Abu Dayyeh

https://pubmed.ncbi.nlm.nih.gov/27465076

Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals.

Barham K Abu Dayyeh, Andres Acosta, Michael Camilleri...

https://pubmed.ncbi.nlm.nih.gov/26748219

Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis.

Mohamad Aghaie Meybodi, Bashar J Qumseya, Delaram Shakoor...

https://pubmed.ncbi.nlm.nih.gov/30842971

Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group.

Babu P Mohan, Saurabh Chandan, Lokesh K Jha...

https://pubmed.ncbi.nlm.nih.gov/31583465