Esophageal Motility DisordersU-POEMNCT06918730
U-POEM vs CO2-POEM
A study testing U-POEM and CO2-POEM in people with Esophageal Motility Disorders, run by AdventHealth at 1 site in United States.
Trial summary
Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- U-POEM and CO2-POEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age 18 years or older
- Ability to provide informed consent
- Patient scheduled to undergo POEM procedure for esophageal dysmotility
Who cannot join
- Inability to provide informed consent
- Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy).
- Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)
Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater).
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications.
Read more
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials
Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.
Aim 2. Compare the proportion of patients that require post-procedural admission for pain management.
Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM.
Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.
Aim 5. Compare and evaluate procedural characteristics between the two groups.
- Compare procedural time between U-POEM and CO2-POEM.
- Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels.
- Adverse event rate (i.e. bleeding, perforation).
- Conditions
- Esophageal Motility Disorders
- Being tested
- U-POEM, CO2-POEM
- Keywords
- POEM, U-POEM, CO2-POEM, Esophageal motility
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-POEMProcedure or surgery
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
CO2-POEMProcedure or surgery
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
| Study group | Role | What they receive |
|---|---|---|
| CO2-POEM | Experimental | POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air. Receives: Procedure: CO2-POEM |
| U-POEM | Experimental | Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation Receives: Procedure: U-POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement outcomes post procedure: Numeric Pain Scale
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.
Using Numeric Pain Scale (NPS)
NPS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
Pain measurement outcomes post procedure: Pain Quality Assessment Scale
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.
Pain Quality Assessment Scale (PQAS).
PQAS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
Secondary outcomes (4)
Readmission rate
Compare the proportion of patients that require post-procedural admission for pain management.
Measured: 30 days post procedure (+- 7 days)
Analgesic medication needs
Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM through electronic medical records.
Measured: 30 days post procedure (+- 7 days)
Compare technical success between POEM procedures
Compare clinical success between U-POEM vs. CO2-POEM. Clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.
Achalasia Severity is measured by the Eckardt Score which consists of 4 questions used to characterize the severity of achalasia.
The questions include symptoms related to:
- Dysphagia
- Chest pain
- Regurgitation
- 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: up to 6 months
Compare technical success between POEM procedures
Compare technical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start11 Feb 2025
- Primary completion30 Oct 2025
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of South Florida
- Responsible party
- Sponsor
- Investigators
- Dennis Yang, MD, Principal investigator, AdventHealth Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918730
- Sponsor's protocol ID
- 2263975
- Acronym
- U-POEM
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859.
PubMed 31287522Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380.
PubMed 31800987Yang D, Bechara R, Dunst CM, Konda VJA. AGA Clinical Practice Update on Advances in Per-Oral Endoscopic Myotomy (POEM) and Remaining Questions-What We Have Learned in the Past Decade: Expert Review. Gastroenterology. 2024 Dec;167(7):1483-1490. doi: 10.1053/j.gastro.2024.08.038. Epub 2024 Oct 16.
PubMed 39425737Reddy CA, Tavakkoli A, Abdul-Hussein M, Almazan E, Vosoughi K, Ichkhanian Y, Al-Hawary M, Chang AC, Chen JW, Korsnes S, Elmunzer BJ, Khashab MA, Law R. Clinical impact of routine esophagram after peroral endoscopic myotomy. Gastrointest Endosc. 2021 Jan;93(1):102-106. doi: 10.1016/j.gie.2020.05.046. Epub 2020 Jun 3.
PubMed 32504702Benias PC, Korrapati P, Raphael KL, D'Souza LS, Inamdar S, Trindade AJ, Lee C, Kumbhari V, Sejpal DV, Okolo P, Khashab MA, Miller L, Carr-Locke D. Safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge. Gastrointest Endosc. 2019 Oct;90(4):570-578. doi: 10.1016/j.gie.2019.04.247. Epub 2019 May 10.
PubMed 31078571Cloutier Z, Mann A, Doumouras AG, Hong D. Same-day discharge is safe and feasible following POEM surgery for esophageal motility disorders. Surg Endosc. 2021 Jul;35(7):3398-3404. doi: 10.1007/s00464-020-07781-4. Epub 2020 Jul 9.
PubMed 32648037Maeda Y, Hirasawa D, Fujita N, Obana T, Sugawara T, Ohira T, Harada Y, Yamagata T, Suzuki K, Koike Y, Yamamoto Y, Kusaka Z, Noda Y. A pilot study to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with carbon dioxide insufflation. Endoscopy. 2012 Jun;44(6):565-71. doi: 10.1055/s-0031-1291664. Epub 2012 Mar 9.
PubMed 22407383Pannu D, Yang D, Abbitt PL, Draganov PV. Prospective evaluation of CT esophagram findings after peroral endoscopic myotomy. Gastrointest Endosc. 2016 Sep;84(3):408-15. doi: 10.1016/j.gie.2016.02.022. Epub 2016 Feb 22.
PubMed 26907745Lee JY, Lim CH, Kim DH, Jung HY, Youn YH, Jung DH, Park JC, Moon HS, Hong SJ; Therapeutic Endoscopy and Instrument for Functional Gastrointestinal Disorders Study Group Under the Korean Society of Neurogastroenterology and Motility. Adverse Events Associated With Peroral Endoscopic Myotomy Affecting Extended Hospital Stay: A Multi-center Retrospective Study in South Korea. J Neurogastroenterol Motil. 2022 Apr 30;28(2):247-254. doi: 10.5056/jnm21081.
PubMed 35362451Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.
PubMed 24218307Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.
PubMed 24890443Binmoeller KF, Bhat YM. Underwater peroral endoscopic myotomy. Gastrointest Endosc. 2016 Feb;83(2):454. doi: 10.1016/j.gie.2015.08.066. Epub 2015 Sep 8. No abstract available.
PubMed 26358328Uchima H, Colan J, Marin I, Moreno V, Larios G, Tazi R, Serra J. Underwater peroral endoscopic myotomy (u-POEM) after tension capnoperitoneum and capnothorax during POEM. Endoscopy. 2020 Nov;52(11):E396-E397. doi: 10.1055/a-1144-2547. Epub 2020 Apr 17. No abstract available.
PubMed 32303086Capogreco A, de Sire R, Massimi D, Alfarone L, Maselli R, Hassan C, Repici A. Underwater coagulation using hybrid knife in peroral endoscopic myotomy for achalasia. Endoscopy. 2024 Jul;56(7):547-548. doi: 10.1055/a-2292-8460. Epub 2024 Jun 27. No abstract available.
PubMed 38936349Yang D, Pannu D, Zhang Q, White JD, Draganov PV. Evaluation of anesthesia management, feasibility and efficacy of peroral endoscopic myotomy (POEM) for achalasia performed in the endoscopy unit. Endosc Int Open. 2015 Aug;3(4):E289-95. doi: 10.1055/s-0034-1391965. Epub 2015 May 5.
PubMed 26357672
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)
- ClinicalTrials.gov ID
- NCT06918730
- Acronym / sponsor ID
- U-POEM / 2263975
- Conditions
- Esophageal Motility Disorders
- Keywords
- POEM, U-POEM, CO2-POEM, Esophageal motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of South Florida
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 9 Apr 2025 (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.
Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater).
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications.
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials
Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.
Aim 2. Compare the proportion of patients that require post-procedural admission for pain management.
Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM.
Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.
Aim 5. Compare and evaluate procedural characteristics between the two groups.
- Compare procedural time between U-POEM and CO2-POEM.
- Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels.
- Adverse event rate (i.e. bleeding, perforation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2-POEM | Experimental | Procedure: CO2-POEMPOEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air. |
| U-POEM | Experimental | Procedure: U-POEMWater immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Ability to provide informed consent
- Patient scheduled to undergo POEM procedure for esophageal dysmotility
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy).
- Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
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 |
|---|---|---|
| U-POEMWater immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation | Procedure or surgery | U-POEM |
| CO2-POEMPOEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air. | Procedure or surgery | CO2-POEM |
Primary outcome
Pain measurement outcomes post procedure: Numeric Pain Scale
Time frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Using Numeric Pain Scale (NPS) NPS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Pain measurement outcomes post procedure: Pain Quality Assessment Scale
Time frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Pain Quality Assessment Scale (PQAS). PQAS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
4 secondary outcomes
Readmission rate
Time frame: 30 days post procedure (+- 7 days)
Analgesic medication needs
Time frame: 30 days post procedure (+- 7 days)
Compare technical success between POEM procedures
Time frame: up to 6 months
Compare technical success between POEM procedures
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 31287522Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859.
- Background: PubMed 31800987Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380.
- Background: PubMed 39425737Yang D, Bechara R, Dunst CM, Konda VJA. AGA Clinical Practice Update on Advances in Per-Oral Endoscopic Myotomy (POEM) and Remaining Questions-What We Have Learned in the Past Decade: Expert Review. Gastroenterology. 2024 Dec;167(7):1483-1490. doi: 10.1053/j.gastro.2024.08.038. Epub 2024 Oct 16.
- Background: PubMed 32504702Reddy CA, Tavakkoli A, Abdul-Hussein M, Almazan E, Vosoughi K, Ichkhanian Y, Al-Hawary M, Chang AC, Chen JW, Korsnes S, Elmunzer BJ, Khashab MA, Law R. Clinical impact of routine esophagram after peroral endoscopic myotomy. Gastrointest Endosc. 2021 Jan;93(1):102-106. doi: 10.1016/j.gie.2020.05.046. Epub 2020 Jun 3.
- Background: PubMed 31078571Benias PC, Korrapati P, Raphael KL, D'Souza LS, Inamdar S, Trindade AJ, Lee C, Kumbhari V, Sejpal DV, Okolo P, Khashab MA, Miller L, Carr-Locke D. Safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge. Gastrointest Endosc. 2019 Oct;90(4):570-578. doi: 10.1016/j.gie.2019.04.247. Epub 2019 May 10.
- Background: PubMed 32648037Cloutier Z, Mann A, Doumouras AG, Hong D. Same-day discharge is safe and feasible following POEM surgery for esophageal motility disorders. Surg Endosc. 2021 Jul;35(7):3398-3404. doi: 10.1007/s00464-020-07781-4. Epub 2020 Jul 9.
- Background: PubMed 22407383Maeda Y, Hirasawa D, Fujita N, Obana T, Sugawara T, Ohira T, Harada Y, Yamagata T, Suzuki K, Koike Y, Yamamoto Y, Kusaka Z, Noda Y. A pilot study to assess mediastinal emphysema after esophageal endoscopic submucosal dissection with carbon dioxide insufflation. Endoscopy. 2012 Jun;44(6):565-71. doi: 10.1055/s-0031-1291664. Epub 2012 Mar 9.
- Background: PubMed 26907745Pannu D, Yang D, Abbitt PL, Draganov PV. Prospective evaluation of CT esophagram findings after peroral endoscopic myotomy. Gastrointest Endosc. 2016 Sep;84(3):408-15. doi: 10.1016/j.gie.2016.02.022. Epub 2016 Feb 22.
- Background: PubMed 35362451Lee JY, Lim CH, Kim DH, Jung HY, Youn YH, Jung DH, Park JC, Moon HS, Hong SJ; Therapeutic Endoscopy and Instrument for Functional Gastrointestinal Disorders Study Group Under the Korean Society of Neurogastroenterology and Motility. Adverse Events Associated With Peroral Endoscopic Myotomy Affecting Extended Hospital Stay: A Multi-center Retrospective Study in South Korea. J Neurogastroenterol Motil. 2022 Apr 30;28(2):247-254. doi: 10.5056/jnm21081.
- Background: PubMed 24218307Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.
- Background: PubMed 24890443Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.
- Background: PubMed 26358328Binmoeller KF, Bhat YM. Underwater peroral endoscopic myotomy. Gastrointest Endosc. 2016 Feb;83(2):454. doi: 10.1016/j.gie.2015.08.066. Epub 2015 Sep 8. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dennis Yang, MD principal investigator
AdventHealth Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-POEM and CO2-POEM in people with Esophageal Motility Disorders, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain measurement outcomes post procedure: Numeric Pain Scale (time frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)). The study lists 2 primary outcomes in all. 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 NCT06918730, which also lists 23 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 15 May 2026.