Recruiting

Endoscopic Antral Myotomy

Sponsor:

Christopher C. Thompson, MD, MSc

Code:

NCT05711758

Conditions

Obesity

Obesity, Morbid

Obesity, Primary

Metabolic Disease

Delayed Gastric Emptying Following Procedure

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PSAM Treatment Patients

Study Details

Brief summary:

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.

Conditions

Obesity

Obesity, Morbid

Obesity, Primary

Metabolic Disease

Delayed Gastric Emptying Following Procedure

Study ID

NCT05711758

Start date

Sep 22, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

PSAM Treatment Patients with no prior endoscopic bariatric therapies

Subjects with no prior endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

PSAM Treatment Patients with prior primary endoscopic bariatric therapies

Subjects with prior primary endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

PSAM Treatment Patients with prior revision endoscopic bariatric therapies

Subjects with prior revision endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

Interventions

PSAM Treatment Patients

PSAM is a pylorus-sparing antral myotomy performed under general anesthesia. Endoscopic myotomy is then performed applying the principles of submucosal endoscopy and techniques used during gastric per-oral endoscopic myotomy (G-POEM). A submucosal bleb is created proximal to the pylorus. A longitudinal mucosal incision is made with an endoscopic knife. The endoscope is then introduced into the submucosal space, and the knife is used to dissect the submucosal fibers. Antral myotomy is performed starting proximal to the pyloric ring extending to the mucosal access site. The myotomy entails cutting of the inner circular and oblique muscle bundles or may be full thickness at the discretion of the endoscopist. The mucosal entry is then closed using endoscopic suturing or clips.

Primary outcome measure

  • Weight change compared to baseline [ Time Frame: Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months ]
  • Adverse Events [ Time Frame: Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months ]
  • Change in tolerability from procedure day to 12 months [ Time Frame: Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months ]

Central Contacts and Locations

Central contacts

Michele B. Ryan, MS

6176765928mryan@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michele B. Ryan, MS

6175258266mryan@bwh.harvard.edu

Principal Investigator:

Christopher C. Thompson, MD, MSc

More Information

Sponsor

Christopher C. Thompson, MD, MSc

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Pylorus Sparing Antral Myotomy (PSAM)
  • Gastric physiology
  • Gastric emptying
  • Pylorus-sparing antral myotomy
  • Myotomy
  • Endoscopic Sleeve Gastroplasty (ESG)
  • TransPyloric Shuttle (TPS)
  • Intragastric balloon (IGB)
  • Endoscopic bariatric and metabolic therapies (EBMT)
  • Gut Hormones
  • Gastric Emptying Breath Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher C. Thompson, MD, MSc on 2026-03-02.