Treatment for low-flow venous malformations using electrosclerotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on treating low-flow venous malformations using electrosclerotherapy with Bleomycin, a widely used sclerosing agent. The study aims to evaluate the effectiveness and safety of this minimally invasive treatment method, which is known for its low rate of serious adverse events. Patients diagnosed with eligible venous malformations will be monitored for outcomes following the treatment. The study will include individuals who have not undergone embolizing treatment and have had at least 30 days since any previous treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Emilia-Romagna, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.