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NCT Number: NCT06189092

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

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.

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Key information

Conditions

Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location status: Recruiting

Location contact

Giancarlo Facchini, MD

CONTACT

[email protected]

+39 333 650 0944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bleomycin

Drug

Using electroporation to infuse bleomycin in the lesion

Primary outcomes

  1. Volume reduction in cm

    Time frame: 1 year

    Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.

Secondary outcomes

  1. Reduction of pain (VAS score)

    Time frame: 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.

  2. Improvement in quality of life ( EuroQol-5D questionnaire)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: BESVAM

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 3, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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