An interventional study of Conventional POEM and Sling Fiber-Preserving POEM in Achalasia, Esophageal and GERD (Gastroesophageal Reflux Disease), sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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Among 52 studies in Esophageal Achalasia with a site in United States — 18 open to participants now, 18 under way, 2 of them phase 3. Esophageal Achalasia · United States.
Among the 52 studies in Esophageal Achalasia with a site in United States, this one is the 8th largest by planned enrollment of the 33 interventional ones that give a count, is the only one that started in 2025, is one of 23 with no phase, reaches primary completion later than 8 of the 17 other live ones, and was the 47th registered.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
Browse Esophageal Achalasia studies →18 of the 52 studies in Esophageal Achalasia with a site in United States are open now. Recruiting first, the newest first:
Northwestern University · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 5–21
Northwestern University · Sites in United States
Ages 18+
Baylor College of Medicine · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 31 Esophageal Achalasia studies recruiting now, 20 (65%) set no upper age limit and 5 (16%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 2 · Phase 4 4
First in 1999; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 56 across 95 interventional studies indexed under Esophageal Achalasia.
Median enrollment 42 across the 33 interventional studies, 200 across the 19 observational. Of the 26 that completed or were terminated, 1 (4%) have results posted.
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1 of 52 have an industry lead sponsor. The 10 most frequent:
University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
University of California, Irvine has 1 study filed under Esophageal Achalasia — fewer than ten, so there is no comparison to draw.
4 of the studies in Esophageal Achalasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04640753Methodist Health SystemPeroral Endoscopic Myotomy for the Treatment of Achalasia | 2027-02-05 |
| NCT07780981Johns Hopkins UniversityImpact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions | 2027-07-01 |
| NCT07496840Baylor College of MedicineClinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM) | 2027-07-30 |
| NCT05550194Vanderbilt University Medical CenterVZV in the Enteric Nervous System: Pathogenesis and Consequences | 2027-08 |
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Among the 52 studies in Esophageal Achalasia with a site in United States, from their registry updates:
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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.
Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, reported in up to 65% of cases. One proposed technical modification - the selective preservation of gastric sling fibers - may help reduce reflux by maintaining part of the native anti-reflux mechanism.
This is a single-blinded, multicenter randomized controlled trial comparing sling fiber preservation (SFP) POEM versus conventional POEM in adult patients with achalasia. Patients are randomized 1:1 to either technique. The primary endpoint is the incidence of significant reflux esophagitis (LA esophagitis grade B or higher) at 3 months post-procedure endoscopy. Secondary outcomes include acid exposure time on pH impedence monitoring, symptomatic reflux (GerdQ), PPI usage, technical and clinical success, and adverse events. Follow-up continues for 12 months.
The study aims to determine whether the SFP-POEM technique reduces acid reflux without compromising treatment efficacy.
Inclusion Criteria (Participants must meet all of the following):
Exclusion Criteria (Participants will be excluded if any of the following apply):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.
Procedure: Conventional POEM
Participants in this arm will undergo posterior POEM with selective preservation of the gastric sling fibers. Myotomy is performed to the right of the second penetrating vessel to spare the sling fibers. The double scope technique will be employed to confirm that the tunnel ends on the lesser curve, which confirms sparing of the sling fibers.
Procedure: Sling Fiber-Preserving POEM
Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.
Also known as: SFP-POEM
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
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.
Time frame: 3 months post-procedure
Esophageal Acid Exposure
Esophageal acid exposure will be measured by 24-hour Bravo pH monitoring performed off PPIs for at least 2 weeks. Reflux severity is quantified using acid exposure time (%) and the DeMeester composite score. The DeMeester score has no fixed maximum; higher values indicate greater esophageal acid exposure. Pathologic reflux is defined as acid exposure time \>6% and/or a DeMeester score \>14.72.
Time frame: 3 months post-procedure
Symptomatic Gastroesophageal Reflux (GerdQ Score)
Symptom-based GERD assessment will be measured using the Gastroesophageal Reflux Disease Questionnaire (GerdQ), which ranges from 0 to 18. Higher scores indicate more frequent or severe reflux symptoms, while lower scores indicate fewer or no symptoms. A score \>7 is considered clinically significant.
Time frame: 3, 6, 12 months post-procedure
Proton Pump Inhibitor (PPI) Use
Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control.
Time frame: 3, 6, 12 months post-procedure
Clinical Success (Eckardt Symptom Score ≤ 3)
Symptom improvement will be measured using the Eckardt Symptom Score, which ranges from 0 to 12. Higher scores indicate more severe symptoms (dysphagia, chest pain, regurgitation, and weight loss), while lower scores indicate symptom improvement. A score ≤ 3 is considered a successful clinical outcome.
Time frame: 3, 6 and 12 months post-procedure
Technical Success
Technical success defined as completion of full-length myotomy as planned.
Time frame: During procedure
Adverse Events
Monitoring of intra- and post-procedural complications, including bleeding, perforation, capno-peritoneum, leak, infection, and other unexpected events.
Time frame: Within 1 month post-procedure
Plan to share: No — Individual participant data (IPD) will not be shared outside the study team. The current protocol does not include provisions for public or external data sharing.
Start is estimated for Dec 2025; primary completion for Dec 2027, 24 months later.
Of 32 interventional studies with no phase under Esophageal Achalasia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of California, Irvine →