Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study

Vascular Malformations Clinical Trial

— BESVAM  

Official title:

Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189092
• Other study ID #: CE AVEC: 639/2023/Oss/IOR
• Status: Recruiting
• Start date: October 28, 2023
• Est. completion date: November 28, 2027

Study information

• Verified date: December 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: November 28, 2027
• Est. primary completion date: November 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
• Non-indication for embolizing treatment
• Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.

Exclusion Criteria:

• Previous treatment for < 30 days
• Pregnancy and lactation status
• Patients of childbearing age without contraceptive use
• Presence of metal synthetic media
• COPD with FiO2 < 30 mmHg
• Impaired renal function with eGFR<30 ml/min/1.73mq
• Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
• Patients who have already received a cumulative dose of Bleomycin =100 mg
• Patients who have undergone prior thoracic radiotherapy
• Patients with a history of seizures and epilepsy

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Malformations

Intervention

Drug:
• Bleomycin
Using electroporation to infuse bleomycin in the lesion

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume reduction in cm	Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.	1 year
Secondary	Reduction of pain (VAS score)	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.	1 year
Secondary	Improvement in quality of life ( EuroQol-5D questionnaire)	Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0.; The 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.	1 year