Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-07 @ 12:13 AM
Study NCT ID:
NCT03057067
Status:
TERMINATED
Last Update Posted:
2019-02-08
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital are eligible for initial assessment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'difficulties recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chronic pelvic pain', 'timeFrame': '3 months', 'description': 'assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain'}, {'measure': 'chronic pelvic pain', 'timeFrame': '6 months', 'description': 'assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain'}, {'measure': 'chronic pelvic pain', 'timeFrame': '1 year', 'description': 'assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life (HRQOL)', 'timeFrame': '3 months', 'description': 'based on the SF-8 and mental health measurements based on the 5-mental health inventory'}, {'measure': 'Health related quality of life (HRQOL)', 'timeFrame': '6 months', 'description': 'based on the SF-8 and mental health measurements based on the 5-mental health inventory'}, {'measure': 'Health related quality of life (HRQOL)', 'timeFrame': '1 year', 'description': 'based on the SF-8 and mental health measurements based on the 5-mental health inventory'}, {'measure': 'Sexual function', 'timeFrame': '3 months', 'description': 'assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)'}, {'measure': 'Sexual function', 'timeFrame': '6 months', 'description': 'assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)'}, {'measure': 'Sexual function', 'timeFrame': '1 year', 'description': 'assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Embolization, Therapeutic', 'Pelvis'], 'conditions': ['Pelvic Pain', 'Varicose Veins']}, 'descriptionModule': {'briefSummary': 'Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.\n\nPelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pelvic pain (lasting for more than 6 months)\n* Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).\n* Confirmed pelvic varicosities by magnetic resonance examination.\n* Signed, written and informed consent\n\nExclusion Criteria:\n\n* Inability to communicate in Norwegian\n* Known endometriosis\n* Uterine myoma, uterine anomalies, or cancer\n* Postmenopausal\n* not having been pregnant'}, 'identificationModule': {'nctId': 'NCT03057067', 'briefTitle': 'Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome', 'orgStudyIdInfo': {'id': '2016/1881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pelvic vein embolization', 'description': 'female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway', 'interventionNames': ['Procedure: Embolization of pelvic vein varicosities']}], 'interventions': [{'name': 'Embolization of pelvic vein varicosities', 'type': 'PROCEDURE', 'description': 'Embolization of pelvic vein varicosities', 'armGroupLabels': ['pelvic vein embolization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Risa AM Lonnee-Hoffmann, md phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}