Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-24 @ 3:03 AM
Study NCT ID:
NCT01402518
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-Oral Endoscopic Myotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-08', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To assess the quality of life, pain, and complications of the POEM approach', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['achalasia', 'myotomy', 'endoscopic myotomy', 'difficulty swallowing'], 'conditions': ['Achalasia']}, 'descriptionModule': {'briefSummary': 'This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Diagnosis of achalasia\n2. Age 18-75\n3. Mentally competent to give informed consent\n4. Scheduled to undergo a POEM procedure\n\nExclusion:\n\n1. Pregnant women\n2. Any prior surgical treatment for achalasia'}, 'identificationModule': {'nctId': 'NCT01402518', 'acronym': 'POEM', 'briefTitle': 'Per-Oral Endoscopic Myotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure', 'orgStudyIdInfo': {'id': '091170, 150261'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Per-oral endoscopic myotomy', 'interventionNames': ['Procedure: Per-oral enodscopic myotomy']}], 'interventions': [{'name': 'Per-oral enodscopic myotomy', 'type': 'PROCEDURE', 'otherNames': ['POEM'], 'armGroupLabels': ['Per-oral endoscopic myotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Santiago Horgan, M.D., FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Santiago Horgan', 'investigatorAffiliation': 'University of California, San Diego'}}}}