[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530616":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":20,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":22,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Performed electrosclerotherapy",null,"All patients who performed electrosclerotherapy in the treatment of vascular malformations",[13],"Drug: Bleomycin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Bleomycin","Using electroporation to infuse bleomycin in the lesion",[9],[21],{"facility":5,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"RECRUITING","Bologna","Emilia-Romagna","40136","Italy","IT",{"type":29,"coordinates":30},"Point",[31,32],11.33875,44.49381,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Giancarlo Facchini, MD","CONTACT","+39 333 650 0944","giancarlo.facchini@ior.it",{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100530616","treatment-of-low-flow-venous-malformations-with-electrosclerotherapy-prospective-observational-study-100530616",false,"NCT06189092","Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study","Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico","BESVAM","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 \\\u003C 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 \\\u003C 30 mmHg\n* Impaired renal function with eGFR\\\u003C30 ml\u002Fmin\u002F1.73mq\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","ALL","16 Years",{"count":53,"type":54},65,"ESTIMATED","1 Year","OBSERVATIONAL","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.",[59],"Vascular Malformations",[61],"Electrosclerotherapy","2026-05-20",{"date":64,"type":65},"2026-05-22","ACTUAL",{"date":67,"type":65},"2023-10-28",{"date":69,"type":54},"2027-11-28",{"name":5,"class":6},1]