[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"achalasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:achalasia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,40,60,82,110,135,162,185,211,239,266,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100631143","clinical-outcomes-safety-and-effectiveness-of-speedboat-ultraslim-in-per-oral-endoscopic-myotomy-poem-100631143",false,"NCT07496840","Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)","Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)","SU-POEM","Inclusion Criteria:\n\n* Adult patients (≥18 years of age)\n* Diagnosed with achalasia or other esophageal motility disorders\n* Scheduled to undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients not considered appropriate candidates for POEM by the principal investigator or treating physician","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","This study is a prospective registry designed to evaluate the clinical outcomes, safety, and effectiveness of per-oral endoscopic myotomy (POEM) performed using the Speedboat UltraSlim™ device in patients with achalasia or other esophageal motility disorders.\n\nParticipants included in this registry are those undergoing clinically indicated POEM as part of standard of care. No experimental interventions will be performed as part of this study. Patients will be approached for participation after the clinical decision to perform POEM has already been made.\n\nData will be collected through review of electronic medical records and procedural documentation, including patient demographics, procedural details, and clinical outcomes. Follow-up data will be collected at predefined time points (e.g., 30 days, 3 months, 6 months, and up to 1 year) to assess symptom improvement, procedural success, and adverse events.\n\nThe primary objective of the study is to assess technical success, clinical success, and safety outcomes associated with the use of the Speedboat UltraSlim™ device during POEM procedures.\n\nThis registry poses minimal risk to participants, as all procedures are performed as part of routine clinical care. No additional interventions beyond standard care are required for participation.",[25,26],"Esophageal Motility Disorders","Achalasia","RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-17","ACTUAL",{"date":33,"type":31},"2026-01-15",{"date":35,"type":21},"2027-09-30",{"name":37,"class":38},"Baylor College of Medicine","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":39},"100411684","peroral-endoscopic-myotomy-for-the-treatment-of-achalasia-100411684","NCT04640753","Peroral Endoscopic Myotomy for the Treatment of Achalasia","Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry","Inclusion Criteria:\n\n* Any discharged patient who has undergone clinically indicated and\u002For standard of care POEM for the treatment of Achalasia from 6\u002F2016 to 6\u002F2021.\n* Above or equal to 18 years of age\n\nExclusion Criteria:\n\n* Any patient who has not undergone POEM for the treatment of Achalasia.\n* Below 18 years of age",{"count":48,"type":21},200,"There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06\u002F2016 - 01\u002F2019 \\& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02\u002F2019 - 06\u002F2021",[26],"2026-06-08",{"date":53,"type":31},"2026-06-10",{"date":55,"type":31},"2019-02-06",{"date":57,"type":21},"2027-02-05",{"name":59,"class":38},"Methodist Health System",{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":39},"100481529","phase-4-vzv-in-the-enteric-nervous-system-pathogenesis-and-consequences-100481529","NCT05550194","VZV in the Enteric Nervous System: Pathogenesis and Consequences","Inclusion Criteria:\n\n* Male and female subjects aged 18-75 years old inclusive (females of childbearing potential should be on highly effective contraceptive methods)\n* Fluent in English and mentally capable to provide informed consent who present to Vanderbilt University Medical Center Digestive Diseases Center for treatment of achalasia.\n* Based on standard clinical practice, we anticipate that patients who undergo these treatments will have been formally diagnosed with achalasia and will be fit to undergo the selected treatment intervention.\n* All subjects must be able to undergo timed barium swallow testing, trans-nasal intubation for high-resolution manometry probe, and therapeutic intervention of a 2-month course of valacyclovir 1g TID and two injections of Shingrix over a two-month period.\n\nExclusion Criteria:\n\n* Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included.\n* Current neurologic or cognitive impairment which would make the patient an unsuitable candidate for a research trial.","75 Years",{"count":20,"type":21},"INTERVENTIONAL",[70],"PHASE4","Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder (\"enteric shingles\"). The Investigators recently found that a chronic active VZV infection, a form of enteric shingles, is associated with achalasia, a severe disease in which the passage of food from esophagus to stomach is impaired. We now propose to eradicate VZV to determine whether its association with achalasia is causal, to identify the genetic basis behind VZV reactivation in the esophagus, and the relationship of mast cells to enteric shingles and abdominal pain.",[26],"2026-05-22",{"date":75,"type":31},"2026-05-27",{"date":77,"type":31},"2023-03-27",{"date":79,"type":21},"2026-08",{"name":81,"class":38},"Vanderbilt University Medical Center",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":39},"100631904","prospective-registry-of-esophageal-motility-100631904","NCT07506746","PRospective Registry of Esophageal Motility","PREM","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study.\n2. The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice\n3. Aged \\> 18 years.\n4. Any typical (heartburn or regurgitation) or atypical reflux symptom (Laryngeal Cough, laryngitis, sub-glottic stenosis, globus, laryngeal cancer, vocal cord granuloma, vocal cord irritation, vocal cord polyps and post-nasal drip; Oropharyngeal: Dental erosion, pharyngitis, sore or burning throat, gingivitis and halitosis; Ears and sinuses: Earaches, otitis media and sinusitis; Pulmonary: Chronic bronchitis, pneumonia, aspiration, bronchiectasis, asthma and idiopathic pulmonary fibrosis; Cardiac: Arrhythmia, angina and myocardial infarction; Sleep: Sleep apnoea, sleep deprivation, insomnia, snoring, nightmare and sleep disturbance), but also any obstructive esophageal symptom potentially reflecting a primary or secondary motility disorder (oropharyngeal or esophageal dysphagia, chest pain, bolus impaction). Every patient with a diagnosis of esophageal inflammatory disorder (including EoE and others) or systemic rheumatological condition (scleroderma, systemic sclerosis, lichen planus and others), every patient previously undergone to any anti-reflux surgery, bariatric surgery, endoscopic or surgical esophageal or gastric myotomy (also for gastroparesis) may be included.\n5. Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Not willing to provide informed consent to the inclusion in the registry",true,{"count":91,"type":21},10000,"10 Years","Digestive physiopathology is a branch of gastroenterology aiming to study patients with upper GI symptoms, mainly gastro-esophageal, potentially indicating the presence of Gastroesophageal Reflux Disease (GERD)\u002FBarrett Esophagus (BE) or obstructive esophageal motility disorders (achalasia being the most relevant), but including also other primary motility disorders such as Esophgago-Gastric Junction Outflow Obstruction (EGJOO), Hypercontractile Esophagus (HE), Distal Esophageal Spasm (DES) and other minor disorders. Physiopathological testing encompasses High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, Functional Lumen Imaging Probe (FLIP) assessment. All these tests are designed to provide a clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms, either in naïve patients, as well as after foregut surgery (particularly anti-reflux surgery, achalasia\u002Fprimary motility disorders treatment).",[95,26,96,97,98],"Esophageal Diseases","Eosinophilic Esophagitis","Motility Disorder","GERD",[100],"Esophageal disease; manometry; FLIP, pH-impedance","2026-03-28",{"date":103,"type":31},"2026-04-02",{"date":105,"type":31},"2026-03-09",{"date":107,"type":21},"2041-03",{"name":109,"class":38},"IRCCS San Raffaele",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":118,"studyType":22,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":39},"100572850","disposable-endoscope-platform-in-third-space-endoscopic-procedures-100572850","NCT06738628","Disposable Endoscope Platform in Third Space Endoscopic Procedures","Pilot Prospective Trial to Demonstrate Efficacy, Feasibility, and Safety of a Disposable Endoscope Platform in Third Space Endoscopic Procedures","Inclusion Criteria:\n\n1. Patient is ≥ 18 years old.\n2. Patients can provide informed consent.\n3. Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.\n\nExclusion Criteria:\n\n1. Patient is \\\u003C 18 years old.\n2. Patient refused and\u002For unable to provide consent.\n3. Patient is a pregnant woman.",{"count":20,"type":21},"4 Weeks","This is a prospective, single-arm unblinded study performed at a single tertiary center in the United States. All subjects will receive standard medical care and no experimental interventions are going to be performed. The procedures will be performed by Dr. Mohamed Othman, Dr. Salmaan Jawaid, Dr. Tara Keihanian, and Dr. Fares Ayoub. All patients undergoing third space endoscopic procedures including e-POEM and g-POEM, meeting study inclusion criteria will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approached individually for further discussion about the study and obtaining informed consent.\n\nThe goal of this prospective, pilot trial is to demonstrate the efficacy, feasibility, safety, and clinical outcomes of third space endoscopic procedures completed using a disposable endoscope platform.",[26,121],"Gastroparesis",[123,124,125],"Per-Oral Endoscopic Myotomy","Gastric Per-Oral Endoscopic Myotomy","Disposable Endoscope","NOT_YET_RECRUITING","2026-03-20",{"date":129,"type":31},"2026-03-24",{"date":131,"type":21},"2026-05-30",{"date":133,"type":21},"2027-03-31",{"name":37,"class":38},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":68,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100624231","safety-and-efficacy-of-a-novel-spydrblade-flexible-bipolar-in-poem-100624231","NCT07406945","Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM","Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Multicenter Prospective Study","Inclusion Criteria:\n\n* Patients with 18 years of age or older.\n* Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction.\n* Patients who provide informed consent.\n\nExclusion Criteria:\n\n* Patients who have contraindications for EGD.\n* Patients with an Eckardt score \\\u003C 3 before POEM.\n* Positive diagnosis of Chagas disease.\n* Patients unable to withstand general anesthesia.",{"count":143,"type":21},73,[145],"NA","Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration.\n\nThe severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain.\n\nDiagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution.\n\nWhile there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock).\n\nThe choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.",[26,148],"EGJ Outflow Obstruction",[150,151],"Novel Flexible Bipolar","POEM","2026-02-06",{"date":154,"type":31},"2026-02-12",{"date":156,"type":31},"2024-11-01",{"date":158,"type":21},"2027-04-01",{"name":160,"class":38},"Chinese University of Hong Kong",2,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":151,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":170,"studyType":22,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":39},"100508791","prospective-evaluation-of-the-clinical-utility-of-peroral-endoscopic-myotomy-for-gastrointestinal-motility-disorders-100508791","NCT05905016","Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Scheduled to undergo POEM\n\nExclusion Criteria:\n\n1. Any contraindication to performing endoscopy.\n2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.",{"count":169,"type":21},600,"12 Months","This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.",[26,173,121,174,175],"Esophageal Spasm, Diffuse","Swallowing Disorder","Zenker Diverticulum","2026-01-29",{"date":178,"type":31},"2026-02-02",{"date":180,"type":31},"2021-10-01",{"date":182,"type":21},"2027-04",{"name":184,"class":38},"AdventHealth",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":68,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":161},"100411757","phase-4-comprehensive-esophageal-diagnostics-study-100411757","NCT04641702","Comprehensive Esophageal Diagnostics Study","Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders","Inclusion Criteria:\n\n1. Male or female patients, age 18 and above.\n2. Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020.\n3. Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)\n4. Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)\n5. Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)\n\nExclusion Criteria:\n\n1. Patients younger than 18 years old\n2. Pregnant women\n3. Prisoners\n4. Non-English speaking - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.\n5. Cognitively impaired adults unable to provide informed consent\n6. Cardiac disease in the form of - arrhythmia requiring ICD or pacemaker, baseline bradycardia with HR \\\u003C60 or tachycardia with HR \\> 90, congestive heart failure with ejection fraction \\\u003C35%, history of myocardial infarction, baseline MAP \\\u003C65 or systolic BP \\>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, GFR \\\u003C60 \\[exclusions for Aim 1 only\\]",{"count":193,"type":21},80,[70],"The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.",[26],[198,199,200,201],"lower esophageal sphincter","Functional Lumen Imaging Probe Topography","anti-fibrosis agents","anti-inflammatory agents","2025-11-05",{"date":204,"type":31},"2025-11-10",{"date":206,"type":31},"2021-03-17",{"date":208,"type":21},"2026-12-31",{"name":210,"class":38},"Emory University",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":220,"studyType":22,"phases":4,"briefSummary":221,"conditions":222,"keywords":226,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":39},"100606862","the-use-of-indocyanine-green-fluorescence-icg-during-laparoscopic-heller--dor-100606862","NCT07181070","The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor","The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study","Inclusion Criteria:\n\n* patients with achalasia of type I and II\n* patients undergoing laparoscopic Heller-Dor\n* patients older than 18 years\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age;\n* Uncooperative patients and\u002For patients unable to provide informed consent\n* ASA ≥4\n* BMI ≥30\n* Patients previously treated with other endoscopic\u002Fsurgical procedures (botulinum toxin injections, dilation, POEM, myotomy)\n* Patients with achalasia type III\n* Patients with megaesophagus\n* Allergy to dyes or contrast agents included in the protocol (e.g., indocyanine green, barium, gastrografin)",{"count":219,"type":21},70,"1 Year","The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic. The main gol are:\n\n* If with use of ICG iatrogenic mucosal leaks can be identified and, if necessary, improve the myotomy.\n* Assess the need for postoperative radiographic control using esophagogastric radiography with gastrografin.\n* Compare clinical characteristics, perioperative outcomes, and 12-month postoperative follow-up between the two populations.",[223,26,224,225],"Achalasia, Esophageal","Indocyanine Green (ICG)","Indocyanine Green",[227,228,229],"achalasia","Laparoscopic Heller-Dor","Indocyanine Green Fluorescence","2025-09-18",{"date":232,"type":31},"2025-09-23",{"date":234,"type":31},"2022-11-01",{"date":236,"type":21},"2026-10-31",{"name":238,"class":38},"Federico II University",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":68,"phases":248,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":39},"100530674","phase-3-electrosurgical-modes-for-endoscopic-submucosal-dissection-in-peroral-endoscopic-esophageal-myotomy-100530674","NCT06189859","Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy","Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients undergoing POEM procedure for any esophageal motility disorder\n* Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy\n\nExclusion Criteria:\n\n* Esophageal varices\n* Esophageal neoplasms\n* Non-correctable coagulopathy\n* Failure to provide an informed consent",{"count":247,"type":21},52,[249],"PHASE3","Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.",[26,252],"Achalasia Cardia",[227,151,254,255,256],"ELECTROSURGERY","SPRAY COAGULATION","PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY","2025-05-08",{"date":259,"type":31},"2025-05-13",{"date":261,"type":31},"2024-03-16",{"date":263,"type":21},"2025-08",{"name":265,"class":38},"Cairo University",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":68,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":287,"locationsCount":288},"100519329","poem-f-for-achalasia-international-study-100519329","NCT06042127","POEM-F for Achalasia International Study","Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial","Inclusion criteria:\n\n1. Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.\n2. Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form.\n3. Patients with achalasia type I, II or III who are one of the following:\n\n   * Treatment naïve, or\n   * Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation\n\nExclusion criteria:\n\n1. Patients unable or unwilling to provide consent.\n2. Previous esophageal or gastric surgery.\n3. Prior achalasia treatment including Heller myotomy, POEM.\n4. Sigmoid achalasia, or significant esophageal dilatation \\>6cm in lower esophagus\n5. Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc\n6. Patients with large hiatal hernias (axial length \\> 2 cm and Hill grade \\>2).\n7. Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.\n8. Patients with obesity (Body Mass Index (BMI) ≥ 30).\n9. Pregnant women or those planning pregnancy or breastfeeding women.\n10. Uncorrectable coagulopathy defined by international normalized ratio (INR) \\> 1.5 or platelet count \\\u003C 50000\u002Fµl.","65 Years",{"count":275,"type":21},81,[145],"Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \\~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM.\n\nThis is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes include technical and clinical success rates, adverse events, post-POEM endoscopic and manometry findings as well as patients' symptom scores.\n\nSample size calculation Based on existing pilot comparative data on POEM-F and POEM, it is estimated that 84 patients would be required to demonstrate a difference in post-procedure GERD of 47.6% to 18.2%, with 80% power and false positive rate of 0.05, accounting for 10% loss to follow-up.\n\nPurpose and potential The current study proposal could demonstrate the superiority of POEM-F over POEM in reducing post-procedural GERD. It would also demonstrate the safety and reproducibility of the technique in expert centers across the globe. It could potentially replace conventional POEM as the preferred minimally invasive endoscopic treatment for achalasia.",[26],[151,280,98],"Fundoplication","2024-11-29",{"date":283,"type":31},"2024-12-03",{"date":285,"type":31},"2023-12-01",{"date":236,"type":21},{"name":160,"class":38},7,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":298,"studyType":22,"phases":4,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":39},"100445453","analysis-of-prevalence-and-risk-factors-associated-with-gastroesophageal-reflux-disease-and-esophagitis-after-peroral-endoscopic-myotomy-100445453","NCT05080634","Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy","Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy","Inclusion Criteria:\n\n1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)\n2. Achalasia patients who underwent POEM\n\nExclusion Criteria:\n\n1. Lack of written consent for participation in the study\n2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry",{"count":297,"type":21},100,"5 Years","Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.",[26,98],[302,303],"Peroral endoscopic myotomy","High-resolution esophageal manometry","2021-10-04",{"date":306,"type":31},"2021-10-18",{"date":308,"type":31},"2021-06-01",{"date":310,"type":21},"2026-09-01",{"name":312,"class":38},"Maria Sklodowska-Curie National Research Institute of Oncology"]