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

Study acronym: PSAM
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 31, 2026 to Dec 2027
    • Site contact updated
    v6
  2. Enrollment target: 6 to 30
    • Primary completion date: Sep 21, 2024 to Dec 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Study arms: 1 to 3
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2023 to Sep 21, 2024
    • Study completion date: May 31, 2024 to Dec 31, 2024
    • Start date changed from estimate of Aug 1, 2023 to Sep 22, 2023
    • Site details revised
  4. Start date: May 1, 2023 to Aug 1, 2023
    • Primary completion date: Sep 1, 2023 to Dec 1, 2023
    • Study completion date: Feb 28, 2024 to May 31, 2024
    v3
  5. Start date: Feb 1, 2023 to May 1, 2023
    • Primary completion date: Jul 1, 2023 to Sep 1, 2023
    • Study completion date: Dec 31, 2023 to Feb 28, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05711758
Lead Sponsor Christopher C. Thompson, MD, MSc
Conditions
(from sponsor)		 Obesity, Obesity, Morbid, Obesity, Primary, Metabolic Disease, Delayed Gastric Emptying Following Procedure
Related terms Metabolic Diseases, Obesity, Obesity, Morbid
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov