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NCT05711758 · ClinicalTrials.gov registry record
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
A clinical trial of Obesity and Metabolic Disease, sponsored by Christopher C. Thompson, MD, MSc.
- Recruiting
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05711758: Recruiting study of Obesity and Metabolic Disease, sponsored by Christopher C. Thompson, MD, MSc.
NCT05711758 is a study of Obesity and Metabolic Disease that is actively recruiting participants, run by Christopher C. Thompson, MD, MSc. The registered enrollment target is 30 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05711758, a study of Obesity and Metabolic Disease, is actively recruiting participants, sponsored by Christopher C. Thompson, MD, MSc.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Percent total body weight loss
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 |
What NCT05711758 shows while recruiting
NCT05711758 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower).
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.
NCT05711758 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT05711758?
The interventions under investigation include: PSAM Treatment Patients (PROCEDURE).
Who is sponsoring clinical trial NCT05711758?
This trial is sponsored by Christopher C. Thompson, MD, MSc, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05711758's enrollment target sits among peer trials
30 851st of 1053 higher than 173 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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