Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-02 @ 7:00 AM
Study NCT ID:
NCT01852734
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}, {'id': 'D008863', 'term': 'Microspheres'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2013-05-06', 'studyFirstSubmitQcDate': '2013-05-13', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical effect', 'timeFrame': 'one year', 'description': 'Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques'}], 'secondaryOutcomes': [{'measure': 'reinterventions rate', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Fibroids', 'Arterial Embolization']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective non-randomised study is to examine whether two different microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination.\n\nQuantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization.\n\nAnother purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in OUH analysed retrospectively.', 'detailedDescription': 'Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres until blood flow stop ( " cut the tree" appearance).\n\nGroup 2: 26 patient will be treated with Embosphere; 500-900 µm until "near-stasis" flow stop in the uterine artery.\n\nClinical and Technical success will be examined, and radiological follow-up 3 and 12 months after embolization using MR contrast-enhanced examination in a Bead Block group and only 3 months control in Embosphere group to assess total fibroid burden infraction degree and eventually residual contracts fibroid enhancement.\n\nQuantitative MRI dominant fibroid characteristic for and 3 months after an intervention to examine eventually potential of as a possible predictor of the volumetric response of the uterine fibroid.\n\nRetrospective study compromised all patient treated between January 2001 until January 2011 with follow up to January 2014, and re-intervention as well as complications rate analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic uterus fibroma\n\nExclusion Criteria:\n\n* pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis)\n* gravidity\n* uterus malignancy\n* big subserosal fibroma with stalk diameter of \\<2 cm\n* menopausal women\n* don,t want to be included into the study\n\n * concomitant adenomyosis'}, 'identificationModule': {'nctId': 'NCT01852734', 'briefTitle': 'Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives', 'orgStudyIdInfo': {'id': 'OUH-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'embolizations, uterine fibroid', 'description': 'embolization interventions with microspheres', 'interventionNames': ['Procedure: embolizations ,uterine fibroid', 'Procedure: embolizations']}], 'interventions': [{'name': 'embolizations ,uterine fibroid', 'type': 'PROCEDURE', 'description': '26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop ( " cut the tree" appearance)\n\n26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until "near stasis " flow stop', 'armGroupLabels': ['embolizations, uterine fibroid']}, {'name': 'embolizations', 'type': 'PROCEDURE', 'otherNames': ['microsphere, uterine fibroid'], 'description': 'comparison between the two microspheres', 'armGroupLabels': ['embolizations, uterine fibroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Stevo Duvnjak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Radiologist', 'investigatorFullName': 'Stevo Duvnjak,MD', 'investigatorAffiliation': 'Odense University Hospital'}}}}