Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:43 AM
Study NCT ID:
NCT07305558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microdochectomy for Chronic Non Dilated Single Duct Nipple Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005687', 'term': 'Galactorrhea'}], 'ancestors': [{'id': 'D007775', 'term': 'Lactation Disorders'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nipple discharge', 'timeFrame': 'from first day after surgery to 3 months after surgery', 'description': 'stop of spontaneous and induced nipple discharge by absence of stain on dressing and clothes and by squeezing the nipple'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'from skin incision to closure', 'description': 'operation time is calculated in minutes'}, {'measure': 'Bleeding', 'timeFrame': 'from skin incision to skin closure', 'description': 'Bleeding is evaluated in mm using gravimetric and direct vision methods'}, {'measure': 'post operative pain', 'timeFrame': 'from the day of surgery to one week after surgery', 'description': 'post operative pain is assessed using the visual analogue scale. The total score is out of 10 (1 means painless, 10 means painful)'}, {'measure': 'hospital stay', 'timeFrame': 'from the first day of surgery to 3 days after surgery', 'description': 'hospital stay is recorded in days'}, {'measure': 'wound infection', 'timeFrame': 'from one day to 2 weeks after surgery', 'description': 'wound infection diagnosed by direct vision of pus or ultrasound of the breast'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nipple discharge', 'microdochectomy', 'breast'], 'conditions': ['Nipple Discharge']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy of a new technique in treatment of single milk duct discharge. The main questions it aims to answer are:\n\nDoes ultrasound guided microdochectomy is feasible in non dilated milk duct? What are the surgical outcomes of this technique?\n\nParticipants will:\n\nHad ultrasound microdochectomy After discharge, patients will visit the clinic twice every week for two weeks, a visit or call after 3 month'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'this problem is evident only in female breast', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females above 18 years old with single not dilated milk duct discharge after failure of medical treatment\n\nExclusion Criteria:\n\n* breast cancer\n* patients with multiple or dilated milk duct discharge.\n* contraindications to surgery or \u202canaesthesia\n* patient above 18 years old\n* patients refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT07305558', 'briefTitle': 'Microdochectomy for Chronic Non Dilated Single Duct Nipple Discharge', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Ultrasound Guided Microdochectomy in Chronic Non Dilated Single Duct Nipple Discharge', 'orgStudyIdInfo': {'id': '1248\\27-4-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with single milk duct discharge', 'interventionNames': ['Procedure: ultrasound guided microdochectomy']}], 'interventions': [{'name': 'ultrasound guided microdochectomy', 'type': 'PROCEDURE', 'description': 'ultrasound was used to perform microdochectomy for single not dilated milk duct without cannulation', 'armGroupLabels': ['patients with single milk duct discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Zagazig', 'country': 'Egypt', 'facility': 'faculty of medicine, Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Reham Zakaria, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine, Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'data will be available on demand by direct contact to the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of general surgery', 'investigatorFullName': 'Reham Zakaria Mohamed Ahmed', 'investigatorAffiliation': 'Zagazig University'}}}}