Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-05-23
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
1. Compare procedural time between U-POEM and CO2-POEM.
2. 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.
3. Adverse event rate (i.e. bleeding, perforation).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB
NCT06217055
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
NCT06589869
Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy
NCT03192917
Titration of Intraoperative PEEP in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy
NCT05155371
Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for Transurethral Resection of the Prostate (TURP) Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients
NCT01091779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to provide informed consent
* Patient scheduled to undergo POEM procedure for esophageal dysmotility
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
University of South Florida
OTHER
AdventHealth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dennis Yang, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth Medical Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AdventHealth Orlando
Orlando, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hirschfeld G, Zernikow B. Variability of "optimal" cut points for mild, moderate, and severe pain: neglected problems when comparing groups. Pain. 2013 Jan;154(1):154-159. doi: 10.1016/j.pain.2012.10.008. Epub 2012 Oct 22.
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.
Werner 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.
Yang 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.
Reddy 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.
Benias 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.
Cloutier 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.
Maeda 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.
Pannu 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.
Lee 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.
Cadoni 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.
Hsieh 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.
Binmoeller 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.
Uchima 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.
Capogreco 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.
Yang 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.
Sarkar S, Khanna P, Gunjan D. Anesthesia for Per-oral endoscopic myotomy (POEM) - not so poetic! J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):28-34. doi: 10.4103/joacp.JOACP_179_20. Epub 2021 Dec 3.
Jensen MP, Gammaitoni AR, Olaleye DO, Oleka N, Nalamachu SR, Galer BS. The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. J Pain. 2006 Nov;7(11):823-32. doi: 10.1016/j.jpain.2006.04.003.
Victor TW, Jensen MP, Gammaitoni AR, Gould EM, White RE, Galer BS. The dimensions of pain quality: factor analysis of the Pain Quality Assessment Scale. Clin J Pain. 2008 Jul-Aug;24(6):550-5. doi: 10.1097/AJP.0b013e31816b1058.
Oldenmenger WH, de Raaf PJ, de Klerk C, van der Rijt CC. Cut points on 0-10 numeric rating scales for symptoms included in the Edmonton Symptom Assessment Scale in cancer patients: a systematic review. J Pain Symptom Manage. 2013 Jun;45(6):1083-93. doi: 10.1016/j.jpainsymman.2012.06.007. Epub 2012 Sep 25.
Guidelines for documentation in the gastrointestinal endoscopy setting. Society of Gastroenterology Nurses and Associates, Inc. Gastroenterol Nurs. 1999 Mar-Apr;22(2):69-97. No abstract available.
Maida M, Sferrazza S, Murino A, Lisotti A, Lazaridis N, Vitello A, Fusaroli P, de Pretis G, Sinagra E. Effectiveness and safety of underwater techniques in gastrointestinal endoscopy: a comprehensive review of the literature. Surg Endosc. 2021 Jan;35(1):37-51. doi: 10.1007/s00464-020-07907-8. Epub 2020 Aug 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2263975
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.