Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00519220
Status:
UNKNOWN
Last Update Posted:
2012-08-15
First Post:
2007-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Symptoms in Patients Undergoing a Heller Myotomy
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': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-21', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['achalasia, Heller myotomy'], 'conditions': ['Achalasia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.', 'detailedDescription': 'Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia\n\nExclusion Criteria:\n\n* No patients under the age of 18 will be included'}, 'identificationModule': {'nctId': 'NCT00519220', 'acronym': 'Achalasia', 'briefTitle': 'Outcome of Symptoms in Patients Undergoing a Heller Myotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Short and Long Term Outcomes of Heller Myotomy', 'orgStudyIdInfo': {'id': '105235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'I', 'description': 'Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.', 'interventionNames': ['Other: Symptom questionnaire']}], 'interventions': [{'name': 'Symptom questionnaire', 'type': 'OTHER', 'description': 'Patients will answer questionnaires evaluating their symptoms of achalasia.', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer C. Cooper, B.S.', 'role': 'CONTACT', 'email': 'jcooper@health.usf.edu', 'phone': '813-844-4218', 'phoneExt': '4218'}, {'name': 'Carl B Bowers, R.N.', 'role': 'CONTACT', 'email': 'cbowers@health.usf.edu', 'phone': '813-844-7529', 'phoneExt': '7529'}], 'facility': 'Tampa General Hospital/University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Kenneth Luberice', 'role': 'CONTACT', 'email': 'kluberic@mail.usf.edu', 'phone': '813-844-8219'}, {'name': 'Carl B Bowers, RN', 'role': 'CONTACT', 'email': 'cbowers@health.usf.edu', 'phone': '813-844-7529', 'phoneExt': '7529'}], 'overallOfficials': [{'name': 'Alexander S Rosemurgy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kenneth Luberice', 'investigatorAffiliation': 'University of South Florida'}}}}