Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-24 @ 5:09 AM
Study NCT ID:
NCT05423067
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uterine bleeding', 'timeFrame': 'October 2011 till January 2016'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'october 2011 - may 2015'}, {'measure': 'quality of life', 'timeFrame': 'october 2011 - may 2015'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['permenant occlusion', 'uterine bleeding', 'uterine arteries'], 'conditions': ['Other Abnormal Uterine and Vaginal Bleeding']}, 'descriptionModule': {'briefSummary': 'Prospective observational interventional study , The study done in two phases:\n\n1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months\n2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.', 'detailedDescription': 'Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.\n\nDesign: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.\n\nPatients and Methods: The study done in two phases:\n\n1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months\n2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.\n\nResults: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.\n\nConclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '34 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis\n\nExclusion Criteria:\n\n* patients wishing future fertility\n* endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume'}, 'identificationModule': {'nctId': 'NCT05423067', 'briefTitle': 'Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura Integrated Fertility Center'}, 'officialTitle': 'Interventional Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'Adelhelal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BUAO', 'description': 'The study done in two phases:\n\n1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months\n2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients', 'interventionNames': ['Procedure: bilateral permanent occlusion of uterine arteries']}], 'interventions': [{'name': 'bilateral permanent occlusion of uterine arteries', 'type': 'PROCEDURE', 'description': 'bilateral permanent Occlusion of uterine arteries through abdominal route', 'armGroupLabels': ['BUAO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dekahlia', 'country': 'Egypt', 'facility': 'Mansoura Integrated fertility center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Adel S Helal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura Integrated Fertility Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura Integrated Fertility Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Emad Mohamad Sedeek', 'investigatorAffiliation': 'Mansoura Integrated Fertility Center'}}}}