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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Christopher C. Thompson, MD, MSc
Study ID
NCT05711758
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PSAM Treatment Patients — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Sep 22, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Weight change compared to baseline [ Time Frame: Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele B. Ryan, MS
[email protected]
6175258266
Christopher C. Thompson, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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