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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06189092

Acronym

BESVAM

Enrollment

Registered

2024-01-03

Start date

2023-10-28

Completion date

2027-11-28

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Malformations

Keywords

Electrosclerotherapy

Brief 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.

Interventions

DRUGBleomycin

Using electroporation to infuse bleomycin in the lesion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Volume reduction in cm	1 year	Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.

Secondary

Measure	Time frame	Description
Reduction of pain (VAS score)	1 year	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.
Improvement in quality of life ( EuroQol-5D questionnaire)	1 year	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026