Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-01 @ 8:40 AM
Study NCT ID:
NCT02770859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-25
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C432915', 'term': 'nephronectin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2040-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2040-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved Eckardt Score', 'timeFrame': '5 years', 'description': "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.\n\nThe 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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Achalasia'], 'conditions': ['Achalasia']}, 'referencesModule': {'references': [{'pmid': '41051511', 'type': 'DERIVED', 'citation': '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. 2025 Oct 6. doi: 10.1007/s00464-025-12258-3. Online ahead of print.'}, {'pmid': '36509112', 'type': 'DERIVED', 'citation': 'Jacobs 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.'}, {'pmid': '35467562', 'type': 'DERIVED', 'citation': 'DeWitt 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.'}, {'pmid': '34979118', 'type': 'DERIVED', 'citation': 'DeWitt 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCurrent 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).\n\nPOEM (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over the age of 18 with demonstrated symptoms of Type II or Type III achalasia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18 years of age Referral for the treatment of Achalasia\n\nExclusion Criteria:\n\nLess than 18 years of age; Absence of Achalasia'}, 'identificationModule': {'nctId': 'NCT02770859', 'acronym': 'POEM', 'briefTitle': 'Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository', 'orgStudyIdInfo': {'id': '1410540149'}}, 'armsInterventionsModule': {'interventions': [{'name': 'POEM (Per Oral Endoscopic Myotomy)', 'type': 'PROCEDURE', 'otherNames': ['POEM'], 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202-5121', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'John M DeWitt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Endoscopic Ultrasound', 'investigatorFullName': 'John DeWitt', 'investigatorAffiliation': 'Indiana University'}}}}