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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous treatment for < 30 days

Pregnancy and lactation status

Patients of childbearing age without contraceptive use

Presence of metal synthetic media

Trial population

Patients affected by low-flow vascular malformations

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bleomycin

    Drug

    Using electroporation to infuse bleomycin in the lesion

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Performed electrosclerotherapy1 intervention

Trial outcomes

Primary outcomes

1

Volume reduction in cm

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

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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