Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-25 @ 7:59 PM
Study NCT ID:
NCT06189092
Status:
RECRUITING
Last Update Posted:
2024-10-29
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054079', 'term': 'Vascular Malformations'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume reduction in cm', 'timeFrame': '1 year', 'description': 'Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.'}], 'secondaryOutcomes': [{'measure': 'Reduction of pain (VAS score)', 'timeFrame': '1 year', 'description': 'Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.'}, {'measure': 'Improvement in quality of life ( EuroQol-5D questionnaire)', 'timeFrame': '1 year', 'description': 'Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0.\n\nThe minimum value represents the worst possible health condition. The maximum value of 1.0 represents the best possible health condition. A value of 1.0 indicates that the patient has no problem in any of the five dimensions assessed by the questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrosclerotherapy'], 'conditions': ['Vascular Malformations']}, 'descriptionModule': {'briefSummary': 'Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by low-flow vascular malformations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of low-flow venous malformations eligible for electrosclerotherapy\n* Non-indication for embolizing treatment\n* Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.\n\nExclusion Criteria:\n\n* Previous treatment for \\< 30 days\n* Pregnancy and lactation status\n* Patients of childbearing age without contraceptive use\n* Presence of metal synthetic media\n* COPD with FiO2 \\< 30 mmHg\n* Impaired renal function with eGFR\\<30 ml/min/1.73mq\n* Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related\n* Patients who have already received a cumulative dose of Bleomycin ≥100 mg\n* Patients who have undergone prior thoracic radiotherapy\n* Patients with a history of seizures and epilepsy'}, 'identificationModule': {'nctId': 'NCT06189092', 'acronym': 'BESVAM', 'briefTitle': 'Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': "Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico", 'orgStudyIdInfo': {'id': 'CE AVEC: 639/2023/Oss/IOR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Performed electrosclerotherapy', 'description': 'All patients who performed electrosclerotherapy in the treatment of vascular malformations', 'interventionNames': ['Drug: Bleomycin']}], 'interventions': [{'name': 'Bleomycin', 'type': 'DRUG', 'description': 'Using electroporation to infuse bleomycin in the lesion', 'armGroupLabels': ['Performed electrosclerotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giancarlo Facchini, MD', 'role': 'CONTACT', 'email': 'giancarlo.facchini@ior.it', 'phone': '+39 333 650 0944'}], 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}