NCT06189092 Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
| NCT ID | NCT06189092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Vascular Malformations |
| Study Type | OBSERVATIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-10-28 |
| Primary Completion | 2026-11-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 65 participants in total. It began in 2023-10-28 with a primary completion date of 2026-11-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06189092 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Vascular Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06189092 currently recruiting?
Yes, NCT06189092 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT06189092 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06189092 clinical trial?
NCT06189092 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 65 participants.