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NCT07178821 · ClinicalTrials.gov registry record · NA
Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD
A NA study, sponsored by University of California, Irvine.
- Not yet
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT07178821: Clinical Trial NA study, sponsored by University of California, Irvine.
NCT07178821 is a NA study that has not yet begun recruiting, run by University of California, Irvine. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07178821, a NA study, has not yet begun recruiting, sponsored by University of California, Irvine.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
Primary Outcome
Reflux esophagitis will be assessed by upper endoscopy (EGD) at 3 months post-POEM. Grading will be based on the Los Angeles (LA) Classification. Significant reflux is defined as LA Grade B or higher.
Interventions
- PROCEDURE Conventional POEM
- PROCEDURE Sling Fiber-Preserving POEM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2028-01-01 |
| Phase | NA |
What is known before NCT07178821 opens enrollment
NCT07178821 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Conventional POEM is the first listed.
NCT07178821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07178821 about?
NCT07178821 is a clinical study titled "Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD". Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the...
What is the current status of trial NCT07178821?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-12-01. Estimated completion is 2028-01-01.
What interventions are being tested in trial NCT07178821?
The interventions under investigation include: Conventional POEM (PROCEDURE), Sling Fiber-Preserving POEM (PROCEDURE).
Who is sponsoring clinical trial NCT07178821?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07178821's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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