Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT04744766
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Mammary Duct Excision; How to Improve the Outcome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the assessment of the results as regard the complication and long term follow up is done by a person who is blind as regard the study group of the patient examined'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction and sensation of nipple areolar complex complications', 'timeFrame': '6 months', 'description': 'cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '6 months', 'description': 'eg nipple areolae complex (NAC) sensation, necrosis...etc'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Duct Ectasia Breast', 'Benign Breast Disease']}, 'descriptionModule': {'briefSummary': 'the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision', 'detailedDescription': 'first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfemales with nipple discharge / recurrent peri-ductal mastitis\n\n\\-\n\nExclusion Criteria:\n\n* suspicion or evidence of malignancy'}, 'identificationModule': {'nctId': 'NCT04744766', 'acronym': 'MDE', 'briefTitle': 'Central Mammary Duct Excision; How to Improve the Outcome?', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Central Mammary Duct Excision; How to Improve the Outcome?', 'orgStudyIdInfo': {'id': 'malhussini002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hadfield technique group', 'description': 'central/mammary duct excision is done by the ordinary method described by Hadfield', 'interventionNames': ['Procedure: major duct excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Al Masad technique group', 'description': 'same procedure with de-epithelization of the upper pararaeolar area', 'interventionNames': ['Procedure: major duct excision']}], 'interventions': [{'name': 'major duct excision', 'type': 'PROCEDURE', 'description': '2 methods of major/central mammary duct excision are compared as regard the outcome', 'armGroupLabels': ['Al Masad technique group', 'Hadfield technique group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Main Univeristy Hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mahmoud A. Alhussini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine , Univeristy of Alexandria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}