Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2026-01-07 @ 5:29 AM
Study NCT ID:
NCT02796092
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alaborda@unizar.es', 'phone': '0034 976 76 15 49', 'title': 'Prof. Alicia Laborda', 'organization': 'GITMI (University of Zaragoza)'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Analysis of cost dependent on the hospital/region/country. It cannot be extrapolated.\n\nSmall number of subjects to compare complication rate of both techniques.'}}, 'adverseEventsModule': {'timeFrame': 'Intraoperative, 3, 6, and 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils', 'otherNumAtRisk': 50, 'otherNumAffected': 11, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs', 'otherNumAtRisk': 50, 'otherNumAffected': 5, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Migration of implant or internal device', 'notes': 'Coil migration to the pulmonary artery. Immediate retrieval during the same intervention. No complications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Hematoma of neck', 'notes': 'Post-puncture hematoma of soft tissues of neck No treatment needed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Extravasation of blood', 'notes': 'Ovarian vein extravasation assessed during venography. No consequences. No treatment needed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'title': 'IMPROVEMENT', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'NO IMPROVEMENT', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).\n\nVAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population presenting pre-treatment pain (more than 1 in VAS)'}, {'type': 'SECONDARY', 'title': 'Improvement of Dyspareunia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'title': 'IMPROVEMENT', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'NO IMPROVEMENT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population presenting pre-treatment dyspareunia'}, {'type': 'SECONDARY', 'title': 'Improvement of Urinary Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'title': 'IMPROVEMENT', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'NO IMPROVEMENT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population presenting pre-treatment urinary urgency'}, {'type': 'SECONDARY', 'title': 'Improvement of Dysmenorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'title': 'IMPROVEMENT', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'NO IMPROVEMENT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population presenting pre-treatment dysmenorrhea'}, {'type': 'SECONDARY', 'title': 'Satisfaction With the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '8.22', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).\n\nPatients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Devices Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '18.16', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': 'Number of coils and number of vascular plugs used in each procedure', 'unitOfMeasure': 'devices', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '3295.05', 'spread': '240.08', 'groupId': 'OG000'}, {'value': '4069.79', 'spread': '138.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.', 'unitOfMeasure': 'US Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Intervention Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '44.46', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '29.02', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Total time length of the procedure, from puncture to compression (in minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '33.41', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '19.52', 'spread': '6.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Total fluoroscopy time, recorded by the equipment (in minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Radiation Dose (DAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '354573.00', 'spread': '105047.76', 'groupId': 'OG000'}, {'value': '189935.60', 'spread': '180002.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'DAP, dose area product of the intervention, (in mGy\\*cm\\^2), recorded by fluoroscopy equipment', 'unitOfMeasure': 'mGy*cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Radiation Dose (AK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '947.99', 'spread': '248.45', 'groupId': 'OG000'}, {'value': '320.66', 'spread': '134.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment', 'unitOfMeasure': 'mGy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0499', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperative', 'description': 'Total number of events during the procedure', 'unitOfMeasure': 'minor events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Toral number of events related to the procedure in the follow-up (1 year)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Re-embolization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'OG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'classes': [{'title': 'Re-embolized', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Scheduled re-embolization due to incomplete occlusion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'FG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited based on physician referral in a single specialized center between January 2014 and January 2015. The 1 year follow-up period was finished in February 2016.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibered Platinum Coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)\n\nFibered platinum coils'}, {'id': 'BG001', 'title': 'Vascular Plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)\n\nVascular plugs'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.00', 'spread': '6.26', 'groupId': 'BG000'}, {'value': '44.34', 'spread': '8.45', 'groupId': 'BG001'}, {'value': '42.67', 'spread': '7.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living children', 'classes': [{'categories': [{'measurements': [{'value': '1.86', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '1.78', 'spread': '0.71', 'groupId': 'BG001'}, {'value': '1.82', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Children', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-treatment Visual Analogue Score', 'classes': [{'categories': [{'measurements': [{'value': '7.14', 'spread': '1.55', 'groupId': 'BG000'}, {'value': '7.88', 'spread': '1.01', 'groupId': 'BG001'}, {'value': '7.51', 'spread': '1.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'VAS is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain in orthostatic position', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain in supine position', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dyspareunia', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dysmenorrhea', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Urinary urgency', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of ovarian cystic disease', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of vaginal varicosities', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of vulvar varicosities', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of lower limb varices', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of lower limb varices surgery', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maximum right pelvic venous caliber', 'classes': [{'categories': [{'measurements': [{'value': '7.38', 'spread': '1.19', 'groupId': 'BG000'}, {'value': '7.36', 'spread': '1.22', 'groupId': 'BG001'}, {'value': '7.37', 'spread': '1.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum left pelvic venous caliber', 'classes': [{'categories': [{'measurements': [{'value': '6.78', 'spread': '1.96', 'groupId': 'BG000'}, {'value': '6.66', 'spread': '1.55', 'groupId': 'BG001'}, {'value': '6.72', 'spread': '1.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Varicocele', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ovarian vein reflux', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Waveform change in Valsalva's maneuver", 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All the patients were women referred from a vascular surgeon, diagnosed of pelvic congestion syndrome and pelvic varices by transvaginal ultrasound Doppler aged over 18.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2016-05-27', 'resultsFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-02', 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Scale', 'timeFrame': '12 months', 'description': 'Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).\n\nVAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)'}], 'secondaryOutcomes': [{'measure': 'Improvement of Dyspareunia', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)'}, {'measure': 'Improvement of Urinary Urgency', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)'}, {'measure': 'Improvement of Dysmenorrhea', 'timeFrame': '12 months', 'description': 'Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)'}, {'measure': 'Satisfaction With the Procedure', 'timeFrame': '12 months', 'description': 'Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).\n\nPatients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem.'}, {'measure': 'Number of Devices Used', 'timeFrame': 'intraoperative', 'description': 'Number of coils and number of vascular plugs used in each procedure'}, {'measure': 'Cost of Treatment', 'timeFrame': 'Intraoperative', 'description': 'Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.'}, {'measure': 'Total Intervention Duration', 'timeFrame': 'Intraoperative', 'description': 'Total time length of the procedure, from puncture to compression (in minutes)'}, {'measure': 'Fluoroscopy Time', 'timeFrame': 'Intraoperative', 'description': 'Total fluoroscopy time, recorded by the equipment (in minutes)'}, {'measure': 'Procedure Radiation Dose (DAP)', 'timeFrame': 'Intraoperative', 'description': 'DAP, dose area product of the intervention, (in mGy\\*cm\\^2), recorded by fluoroscopy equipment'}, {'measure': 'Procedure Radiation Dose (AK)', 'timeFrame': 'Intraoperative', 'description': 'AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment'}, {'measure': 'Complications', 'timeFrame': 'intraoperative', 'description': 'Total number of events during the procedure'}, {'measure': 'Complications', 'timeFrame': '12 months', 'description': 'Toral number of events related to the procedure in the follow-up (1 year)'}, {'measure': 'Need for Re-embolization', 'timeFrame': '12 months', 'description': 'Scheduled re-embolization due to incomplete occlusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pelvic Congestion Syndrome', 'Pelvic Venous Insufficiency', 'Chronic pelvic pain'], 'conditions': ['Pelvic Congestion Syndrome']}, 'descriptionModule': {'briefSummary': 'This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.', 'detailedDescription': 'This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Presence of chronic abdominal or pelvic pain for more than 6 months\n* \\>6 mm pelvic venous caliber measured by transvaginal US\n* Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US\n\nExclusion Criteria:\n\n* Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma\n* Glomerular filtration rate \\<60 ml/min\n* History of contrast reaction\n* Patients not able to be followed up for at least one year'}, 'identificationModule': {'nctId': 'NCT02796092', 'briefTitle': 'Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Group of Research in Minimally Invasive Techniques'}, 'officialTitle': 'Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome', 'orgStudyIdInfo': {'id': 'GTM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fibered platinum coils', 'description': 'Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)', 'interventionNames': ['Device: Fibered platinum coils']}, {'type': 'EXPERIMENTAL', 'label': 'Vascular plugs', 'description': 'Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)', 'interventionNames': ['Device: Vascular plugs']}], 'interventions': [{'name': 'Fibered platinum coils', 'type': 'DEVICE', 'otherNames': ['Nester coils'], 'armGroupLabels': ['Fibered platinum coils']}, {'name': 'Vascular plugs', 'type': 'DEVICE', 'otherNames': ['Amplatzer vascular plugs'], 'armGroupLabels': ['Vascular plugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50003', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Lozano Blesa University Hospital', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Miguel A De Gregorio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Group of Research in Minimally Invasive Techniques', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}