AchalasiaPOEMNCT05905016
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
An observational study of Achalasia and Esophageal Spasm, Diffuse, run by AdventHealth at 1 site in United States.
Trial summary
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Esophageal Spasm, Diffuse, Gastroparesis
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to Apr 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.
Who may be able to join
- Age 18 years or older.
- Scheduled to undergo POEM
Who cannot join
- Any contraindication to performing endoscopy.
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Dennis Yang, MD, 407-303-2570, Dennis.Yang.MD@adventhealth.com
About this study
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
Read the detailed description
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
This study will enroll 600 subjects over the next 4 to 5 years.
- Conditions
- Achalasia, Esophageal Spasm, Diffuse, Gastroparesis, Swallowing Disorder, Zenker Diverticulum
- Medical subject headings
- Esophageal Achalasia, Esophageal Spasm, Diffuse, Gastroparesis, Deglutition Disorders, Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal POEM | Data will be collected for patients under going standard of care Esophageal POEM (E-POEM) | |
| Gastric POEM | Data will be collected for patients under going standard of care Gastric POEM (G-POEM) | |
| Zenker's POEM | Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post procedural Reflux Rate
Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM
Measured: 12 months
Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis
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.
Measured: 12 months
Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence
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.
Measured: 12 months
Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Yang, MD, Principal investigator, AdventHealth Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905016
- Sponsor's protocol ID
- 1798543
- Acronym
- POEM
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
- ClinicalTrials.gov ID
- NCT05905016
- Acronym / sponsor ID
- POEM / 1798543
- Conditions
- Achalasia, Esophageal Spasm, Diffuse, Gastroparesis, Swallowing Disorder, Zenker Diverticulum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
Detailed description
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
This study will enroll 600 subjects over the next 4 to 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esophageal POEM | – | –Data will be collected for patients under going standard of care Esophageal POEM (E-POEM) |
| Gastric POEM | – | –Data will be collected for patients under going standard of care Gastric POEM (G-POEM) |
| Zenker's POEM | – | –Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Scheduled to undergo POEM
Key exclusion criteria (2 listed)
- Any contraindication to performing endoscopy.
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Yang, MD principal investigator
AdventHealth Orlando
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Esophageal Spasm, Diffuse, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Yang, MD (407-303-2570, Dennis.Yang.MD@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post procedural Reflux Rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.