Actively Recruiting
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Led by AdventHealth · Updated on 2026-02-02
600
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect prospective data on patients with gastrointestinal motility disorders receiving peroral endoscopic myotomy (POEM) as part of their standard medical care. The study focuses on conditions such as achalasia, diffuse esophageal spasm, gastroparesis, swallowing disorder, and Zenker's diverticulum. No experimental treatments will be administered, and the goal is to evaluate the clinical utility of POEM procedures over time. Participants will undergo one of three types of POEM procedures according to standard care: Esophageal POEM (E-POEM), Gastric POEM (G-POEM), or Zenker's diverticulum POEM (Z-POEM). Data will be collected during their routine treatment without altering their care plan. The study plans to enroll 600 subjects over 4 to 5 years and will monitor outcomes related to reflux rates, long-term clinical efficacy, and recurrence rates over a 12-month period following the procedures. During the study, participants will receive usual medical assessments and care. Researchers will collect information on post-procedure reflux, symptom improvement, and disease management effectiveness up to one year after treatment. No additional experimental interventions will be performed, and the total participation involves observation and data recording alongside standard clinical follow-up provided by the participants' healthcare providers.
CONDITIONS
Brief Title
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled to undergo peroral endoscopic myotomy (POEM)
You will not qualify if you...
- Any contraindication to performing endoscopy
- Participation in another research protocol that could interfere or influence the outcome measures of this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure occurs during routine care
Participants undergo standard medical care with peroral endoscopic myotomy (POEM) for gastrointestinal motility disorders.
1 procedure visit (in-person)
Duration - 12 months
Participants are observed for clinical outcomes and complications for up to 12 months after the procedure.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
Research Team
D
Dennis Yang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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