Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-22 @ 5:43 PM
Study NCT ID:
NCT01525732
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2012-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysphagia score before and after P.O.E.M.', 'timeFrame': 'From 1st day after POEM to within 2 weeks after POEM'}], 'secondaryOutcomes': [{'measure': 'Eckardt score before and after P.O.E.M.', 'timeFrame': 'Before and 1 month after POEM'}, {'measure': 'Post-operative pain', 'timeFrame': 'From Day 1 to until 2 weeks after POEM'}, {'measure': 'Operative time', 'timeFrame': 'Up to 24 hours'}, {'measure': 'Hospital stay', 'timeFrame': 'From day of admission till up to 30 days'}, {'measure': 'Perioperative complication', 'timeFrame': '30 days after operation'}]}, 'conditionsModule': {'keywords': ['Achalasia, Hypertensive LES'], 'conditions': ['Achalasia', 'Hypertensive LES']}, 'referencesModule': {'references': [{'pmid': '23043852', 'type': 'DERIVED', 'citation': 'Chiu PW, Wu JC, Teoh AY, Chan Y, Wong SK, Liu SY, Yung MY, Lam CC, Sung JJ, Chan FK, Lau JY, Ng EK. Peroral endoscopic myotomy for treatment of achalasia: from bench to bedside (with video). Gastrointest Endosc. 2013 Jan;77(1):29-38. doi: 10.1016/j.gie.2012.08.018. Epub 2012 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.\n\nExclusion Criteria:\n\n* Patients will be excluded from this study with the followings -\n\n 1. Pregnancy\n 2. Informed consent not available\n 3. Previous history of esophagectomy or mediastinal surgery\n 4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection\n 5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow'}, 'identificationModule': {'nctId': 'NCT01525732', 'acronym': 'POEM', 'briefTitle': 'Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders', 'orgStudyIdInfo': {'id': 'CRE-2010_430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'POEM', 'description': 'Per Oral Endoscopic Myotomy', 'interventionNames': ['Procedure: Per Oral Endoscopic Myotomy']}], 'interventions': [{'name': 'Per Oral Endoscopic Myotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['POEM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Philip Wai Yan Chiu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}