AchalasiaPOEMNCT02770859
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
An observational study of Achalasia, run by Indiana University at 1 site in United States.
Trial summary
POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achalasia
- What is being tested?
- POEM (Per Oral Endoscopic Myotomy)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2014to 31 Jan 2040
- How long will I take part?
- 60 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 18 with demonstrated symptoms of Type II or Type III achalasia.
Who may be able to join
- 18 years of age Referral for the treatment of Achalasia
Who cannot join
- Less than 18 years of age; Absence of Achalasia
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
Indiana University Hospital
Indianapolis, Indiana, 46202-5121
About this study
POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.
Read the detailed description
Achalasia is a disease of the muscle of the esophagus (food tube) \& means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter [LES]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \& prevents food \& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \& [sometimes] liquids), chest pain \& can experience recurrent pneumonia \& loss of weight.
Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) \& Esophagomyotomy (general surgery to cut the LES).
POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.
- Conditions
- Achalasia
- Being tested
- POEM (Per Oral Endoscopic Myotomy)
- Keywords
- Achalasia
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEM (Per Oral Endoscopic Myotomy)Procedure or surgery
Also called POEM
Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Eckardt Score
Consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response.
The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start16 Oct 2014
- Primary completion31 Jan 2040 (estimated)
- Study completion31 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John DeWitt, Indiana University
- Investigators
- John M DeWitt, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770859
- Sponsor's protocol ID
- 1410540149
- Acronym
- POEM
- Status last verified
- Feb 2026
- First submitted
- 10 May 2016
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
DeWitt J, Stainko S, Perkins A, Rosenheck M, Al-Haddad M. Impact of prior endoscopic or surgical interventions on clinical outcomes after peroral endoscopic myotomy for achalasia. Surg Endosc. 2026 Jan;40(1):174-181. doi: 10.1007/s00464-025-12258-3. Epub 2025 Oct 6.
PubMed 41051511Jacobs CC, Al-Haddad M, Stainko S, Perkins A, DeWitt JM. Prevalence and impact of opioid use in patients undergoing peroral endoscopic myotomy. Gastrointest Endosc. 2023 Apr;97(4):655-663.e2. doi: 10.1016/j.gie.2022.12.006. Epub 2022 Dec 9.
PubMed 36509112DeWitt JM, Kessler WR, Wo JM, Stainko S, Perkins A, Dickason D, Al-Haddad MA, Siwiec R. Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy. Am J Gastroenterol. 2022 Aug 1;117(8):1316-1319. doi: 10.14309/ajg.0000000000001801. Epub 2022 Apr 25.
PubMed 35467562DeWitt JM, Siwiec R, Kessler WR, Wo JM, Stainko S, Picklesimer Doyle M, Perkins A, Dickason D, Al-Haddad MA. Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy. Gastrointest Endosc. 2022 May;95(5):855-863. doi: 10.1016/j.gie.2021.12.029. Epub 2022 Jan 1.
PubMed 34979118
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
- ClinicalTrials.gov ID
- NCT02770859
- Acronym / sponsor ID
- POEM / 1410540149
- Conditions
- Achalasia
- Keywords
- Achalasia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 31 Jan 2040 (estimated)
- Study completion
- 31 Jan 2040 (estimated)
- First posted
- 12 May 2016 (estimated)
- 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.
POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.
Detailed description
Achalasia is a disease of the muscle of the esophagus (food tube) \& means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter [LES]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \& prevents food \& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \& [sometimes] liquids), chest pain \& can experience recurrent pneumonia \& loss of weight.
Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) \& Esophagomyotomy (general surgery to cut the LES).
POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 with demonstrated symptoms of Type II or Type III achalasia.
Key inclusion criteria (1 listed)
- 18 years of age Referral for the treatment of Achalasia
Key exclusion criteria (1 listed)
- Less than 18 years of age; Absence of Achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POEM (Per Oral Endoscopic Myotomy)Also: POEMPer-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia | Procedure or surgery | – |
Primary outcome
Improved Eckardt Score
Time frame: 5 years
Consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response. The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.
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 18 Feb 2026.
- Derived from this study: PubMed 41051511DeWitt J, Stainko S, Perkins A, Rosenheck M, Al-Haddad M. Impact of prior endoscopic or surgical interventions on clinical outcomes after peroral endoscopic myotomy for achalasia. Surg Endosc. 2026 Jan;40(1):174-181. doi: 10.1007/s00464-025-12258-3. Epub 2025 Oct 6.
- Derived from this study: PubMed 36509112Jacobs CC, Al-Haddad M, Stainko S, Perkins A, DeWitt JM. Prevalence and impact of opioid use in patients undergoing peroral endoscopic myotomy. Gastrointest Endosc. 2023 Apr;97(4):655-663.e2. doi: 10.1016/j.gie.2022.12.006. Epub 2022 Dec 9.
- Derived from this study: PubMed 35467562DeWitt JM, Kessler WR, Wo JM, Stainko S, Perkins A, Dickason D, Al-Haddad MA, Siwiec R. Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy. Am J Gastroenterol. 2022 Aug 1;117(8):1316-1319. doi: 10.14309/ajg.0000000000001801. Epub 2022 Apr 25.
- Derived from this study: PubMed 34979118DeWitt JM, Siwiec R, Kessler WR, Wo JM, Stainko S, Picklesimer Doyle M, Perkins A, Dickason D, Al-Haddad MA. Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy. Gastrointest Endosc. 2022 May;95(5):855-863. doi: 10.1016/j.gie.2021.12.029. Epub 2022 Jan 1.
- Individual participant dataSharing planned: Undecided
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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.
John M DeWitt, M.D. principal investigator
Indiana University
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, run by Indiana University 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 18 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Eckardt Score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770859, which also lists 4 linked publications.
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 18 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.