NCT05905016 · AdventHealth
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
(POEM)
What this study is about
This is forward-looking data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
View original scientific description
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
Primary outcome measures
Post procedural Reflux Rate
Time frame: 12 months
Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM
Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis
Time frame: 12 months
The main outcome of the study is to evaluate the proportion of patients who have clinical response to GPOEM. Clinical response is measured by the validated symptom assessment tool (gastroparesis cardinal symptom index - GCSI). Patients with a decrease in GCSI by one or more point will be defined as having a clinical response.
Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence
Time frame: 12 months
The main outcome of this study is to evaluate rate of recurrence of symptoms after Z-POEM for Zenker's diverticulum. Recurrence is defined as a return of patient's symptoms (dysphagia, odynophagia) at the time of clinic follow-up.
Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.
Time frame: 12 months
The main outcome measure is to evaluate the long-term efficacy of POEM for esophageal motility disorders. Efficacy or clinical response is usually assessed using the Eckardt score. An Eckardt score of \< 3 is traditionally defined as treatment response following POEM.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older.
- Scheduled to undergo POEM
Exclusion criteria
- Any contraindication to performing endoscopy.
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Where
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations