Actively Recruiting
Treatment of Low-flow Venous Malformations With Electrosclerotherapy: A Prospective Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-22
65
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Venous malformations are congenital abnormalities in the veins caused by developmental errors during embryogenesis, featuring large venous-like spaces. This research is an observational study evaluating the use of electrosclerotherapy with bleomycin, a drug commonly used as a sclerosing agent for slow-flow vascular malformations, due to its lower risk of serious local side effects compared to other treatments. The study is sponsored by Istituto Ortopedico Rizzoli and focuses on patients with low-flow venous malformations. The treatment involves applying electroporation to deliver bleomycin directly into the lesion. All patients who undergo electrosclerotherapy for vascular malformations are included in the study. This method is less invasive and aims to reduce the volume of the malformations, as well as improve pain and quality of life over time. Participants will be monitored for one year to assess the reduction in volume of the malformations, changes in pain using a visual analog scale, and improvements in quality of life through the EuroQol-5D questionnaire. The study does not include randomization or blinding, and the total time commitment depends on the treatment schedule and follow-up assessments during this period.
CONDITIONS
Brief Title
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
- Not suitable for embolizing treatment
- Previous treatments allowed if at least 30 days have passed
You will not qualify if you...
- Previous treatment within the last 30 days
- Pregnancy or breastfeeding
- Childbearing age without contraceptive use
- Presence of metal synthetic materials
- COPD with FiO2 less than 30 mmHg
- Impaired kidney function with eGFR less than 30 ml/min/1.73mq
- Intolerance or previous toxic reactions to Bleomycin
- Previous cumulative Bleomycin dose of 100 mg or more
- Prior thoracic radiotherapy
- History of seizures or epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive electrosclerotherapy using bleomycin infused by electroporation to treat low-flow venous malformations.
1 treatment visit (in-person)
Duration - Up to 1 year
Participants are monitored for treatment outcomes including volume reduction, pain reduction, and quality of life improvement over 1 year.
Periodic follow-up visits during the year
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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