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Sling Fiber-Preservation POEM for Achalasia

This study is looking at two ways to perform a procedure called Peroral Endoscopic Myotomy (POEM) for people with achalasia. Achalasia is a condition where your esophagus (food pipe) has trouble moving food to your stomach. While POEM is good at treating achalasia, it can sometimes lead to heartburn or reflux (GERD). This study compares the standard POEM procedure with a new approach called Sling Fiber-Preserving POEM. The goal of Sling Fiber-Preserving POEM is to reduce the chance of getting GERD after the surgery by carefully preserving certain muscle fibers. Researchers want to see if this new approach can lower the risk of significant reflux (heartburn) at 3 months after the procedure. You might be able to join if you are at least 18 years old, have achalasia, and are a good candidate for POEM.

Study design
This is a randomized study, meaning participants will be randomly assigned to receive either the standard POEM or the Sling Fiber-Preserving POEM. About 120 people are expected to participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the procedure, with the main check for reflux happening at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07178821

Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of California, Irvine
~120 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Conventional POEMSling Fiber-Preserving POEM

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
Measured over 3 months post-procedure

Conditions

Achalasia, Esophageal
GERD (Gastroesophageal Reflux Disease)

Explore related trials

Achalasia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jason Samarasena, MD, MBA · PRINCIPAL_INVESTIGATOR · University of California, Irvine

Who to contact

Frances Dang, MD, MSc
[email protected]
714-456-6745
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
Deemed appropriate candidates for POEM
Ability to provide informed consent

Exclusion

Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction)
Sigmoid esophagus
Prior surgical myotomy (e.g., Heller myotomy)
Contraindications to endoscopy or general anesthesia
Pregnancy or actively breastfeeding
Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention
Coagulopathy or portal hypertension
Unwillingness or inability to complete follow-up assessments

What this trial measures

  • Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)3 months post-procedure

    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.