Treatment for low-flow venous malformations using electrosclerotherapy
Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
Istituto Ortopedico Rizzoli · NCT06189092
This study is testing if a new treatment using electrosclerotherapy with Bleomycin can safely help people with low-flow venous malformations feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Trial ID | NCT06189092 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with low-flow venous malformations who are eligible for electrosclerotherapy.
Not a fit: Patients with a history of Bleomycin intolerance or those who have received prior thoracic radiotherapy may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and effective option for patients with low-flow venous malformations.
How similar studies have performed: Previous studies have shown success with electrosclerotherapy for similar conditions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, Emilia-Romagna
- Istituto Ortopedico Rizzoli — Bologna, Emilia-Romagna, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vascular Malformations, Electrosclerotherapy