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Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
NCT05711758 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- PROCEDURE PSAM Treatment Patients
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-09-22 |
| Est. Completion | 2027-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05711758
The ClinicalTrials.gov registry entry for NCT05711758 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Christopher C. Thompson, MD, MSc, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention — of which PSAM Treatment Patients is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05711758 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05711758 about?
NCT05711758 is a clinical study titled "Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure". 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 di...
What is the current status of trial NCT05711758?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2023-09-22. Estimated completion is 2027-12.
What conditions does trial NCT05711758 study?
This clinical trial studies the following conditions: Obesity, Metabolic Disease, Obesity, Morbid, Delayed Gastric Emptying Following Procedure, Obesity, Primary. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05711758?
The interventions under investigation include: PSAM Treatment Patients (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05711758?
This trial is sponsored by Christopher C. Thompson, MD, MSc, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05711758 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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