Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-31 @ 10:58 AM
Study NCT ID:
NCT04960293
Status:
UNKNOWN
Last Update Posted:
2021-07-13
First Post:
2021-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-07-11', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score (VAS score)', 'timeFrame': 'up to 24 hours after embolization', 'description': 'Maximum pain score measured during 24 hours after embolization'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'the day before and 24 hours after embolization', 'description': 'inflammatory markers'}, {'measure': 'Tumor necrosis rate after embolization', 'timeFrame': '1 day and 3 months after embolization', 'description': 'technical success indicator'}, {'measure': 'Symptom severity questionnaire', 'timeFrame': 'before and 3 months after embolization', 'description': 'clinical success indicator'}, {'measure': 'White blood cell count (/µL)', 'timeFrame': 'the day before and 24 hours after embolization', 'description': 'inflammatory markers'}, {'measure': 'Neutrophil percentage (%)', 'timeFrame': 'the day before and 24 hours after embolization', 'description': 'inflammatory markers'}, {'measure': 'Cumulative fentanyl dose (µg)', 'timeFrame': 'within 24 hours after embolization', 'description': 'Total amount of IV fentanyl administered'}, {'measure': 'Use of rescue analgesics (%)', 'timeFrame': 'within 24 hours after embolization', 'description': 'Necessity of additional rescue analgesics'}, {'measure': 'Lymphocyte percentage (%)', 'timeFrame': 'the day before and 24 hours after embolization', 'description': 'Inflammatory marker'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibroid', 'Embolization', 'Pain', 'Inflammation'], 'conditions': ['Symptomatic Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids', 'detailedDescription': 'Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Women with symptomatic fibroids (age: 20 - 60 years old)\n\nExclusion Criteria:\n\n1. Bradycardia (\\<45 bpm)\n2. Conduction abnormalities\n3. Liver failure\n4. renal failure\n5. Uncontrolled hypertension\n6. High grade obesity (BMI ≥ 30 kg/m2)\n7. Drug allergy\n8. Illiteracy\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT04960293', 'briefTitle': 'Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': '"Comparison of Pain After Uterine Artery Embolization Using Spherical Gelfoam or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '4-2021-0467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spherical gelfoam', 'description': 'Patients who receive uterine artery embolization for symptomatic fibroids', 'interventionNames': ['Procedure: uterine artery embolization using spherical gelfoam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microsphere', 'description': 'Patients who receive uterine artery embolization for symptomatic fibroids', 'interventionNames': ['Procedure: uterine artery embolization using tri-acryl gelatin microsphere']}], 'interventions': [{'name': 'uterine artery embolization using spherical gelfoam', 'type': 'PROCEDURE', 'description': 'Uterine artery embolization is performed using spherical gelfoam. All other processes are same.', 'armGroupLabels': ['Spherical gelfoam']}, {'name': 'uterine artery embolization using tri-acryl gelatin microsphere', 'type': 'PROCEDURE', 'description': 'Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.', 'armGroupLabels': ['Microsphere']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Man-Deuk Kim', 'role': 'CONTACT', 'email': 'mdkim@yuhs.ac', 'phone': '82-10-8625-2197'}], 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Man-Deuk Kim', 'role': 'CONTACT', 'email': 'mdkim@yuhs.ac', 'phone': '82-10-8625-2197'}], 'overallOfficials': [{'name': 'Man-Deuk Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiology, Severance hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}