Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-11 @ 9:16 PM
Study NCT ID:
NCT04461860
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D013577', 'term': 'Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic congestion pain relief', 'timeFrame': 'pre-embolization and 1 month post-gonadal vein embolization', 'description': 'To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome. A high score means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey', 'timeFrame': 'pre-embolization and 1 month post-gonadal vein embolization', 'description': 'to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.'}, {'measure': 'evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey', 'timeFrame': 'pre-embolization and 1 month post-gonadal vein embolization', 'description': 'to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['syndrome', 'pain', 'pelvic', 'vein', 'embolization'], 'conditions': ['Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'Summary:\n\nMain Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.\n\nThe Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.', 'detailedDescription': "A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome. These patients will be contacted by phone to participate in the study. An information letter will be handed out and the study protocol will be explained to the patients. After obtaining their written consent, they will be asked to fill out the study's validated questionnaire at home and return it to us through pre-paid regular mail. A face to face interview with the patient will be scheduled to assess the correlation between patient's clinical symptoms and survey results. There will be no change in patient's routine follow-up care.\n\nAll physician investigators of the study are experts in their field of medicine (e.g. interventional MRI angiography, vascular disease)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women \\> 18 years old with at least 1 previous pregnancy and delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI\n* Failed medical treatment.\n* \\> 18 years \\< 60 years old\n\nExclusion Criteria:\n\n* \\< 18 years old\n* Under legal guardian\n* Asymptomatic pelvic congestion syndrome\n* Psychiatric disorder\n* Endometriosis.\n* Chronic pelvic disease\n* Pregnancy\n* Neoplasia\n* Acute intermittent porphyria'}, 'identificationModule': {'nctId': 'NCT04461860', 'acronym': 'SCVPC', 'briefTitle': 'Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)', 'orgStudyIdInfo': {'id': 'SCVPC (29BRC20.0089)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe QUEHE', 'role': 'CONTACT', 'email': 'philippe.quehe@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Philippe QUEHE', 'role': 'CONTACT', 'email': 'philippe.quehe@chu-brest.fr', 'phone': '02 98 34 75 45'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning one year and ending five years following the end of the study', 'ipdSharing': 'YES', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}