Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-01 @ 2:29 PM
Study NCT ID:
NCT00204750
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562765', 'term': 'Esophageal Ring, Lower'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'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'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-23', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Recurrence at one year of Schatzki's ring", 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'GERD score at 1,3,6,9,12 month time intervals', 'timeFrame': 'one year'}, {'measure': 'Dysphagia score at 1,3,6,9,12 month time intervals', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lower esophageal ring', 'dysphagia', 'electrosurgical incision', 'bougie dilation', 'GERD'], 'conditions': ['Lower Esophageal Ring', 'Dysphagia']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.", 'detailedDescription': "Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between the ages of 18-80 with symptomatic Schatzki's ring\n* No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision\n\nExclusion Criteria:\n\n* Contraindication to proton pump inhibitors\n* Pregnancy\n* Inability to provide informed consent\n* History of previous esophagogastric surgery\n* Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia\n* Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo esophageal motility testing and ambulatory pH monitoring"}, 'identificationModule': {'nctId': 'NCT00204750', 'briefTitle': "Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings", 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': "A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings", 'orgStudyIdInfo': {'id': '8953'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Bougie dilation', 'interventionNames': ['Procedure: Bougie Dilation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Needle-knife incision', 'interventionNames': ['Procedure: Needle-knife incision']}], 'interventions': [{'name': 'Bougie Dilation', 'type': 'PROCEDURE', 'otherNames': ['Maloney dilation'], 'description': 'Bougie dilation will be performed as standard', 'armGroupLabels': ['1']}, {'name': 'Needle-knife incision', 'type': 'PROCEDURE', 'description': 'Needle-knife incision will be performed', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah HSC', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'John Fang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Utah HSC'}, {'name': 'James A DiSario, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah HSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'PriCara, Unit of Ortho-McNeil, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'University of Utah', 'oldOrganization': 'University of Utah'}}}}