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

NCT06189092 | Recruiting

• 1 other identifier: CE AVEC: 639/2023/Oss/IOR
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Malformations

Keywords

Electrosclerotherapy

Outcome Measures

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.

  1 year

Secondary Outcomes (2)

• Reduction of pain (VAS score)

  1 year

• Improvement in quality of life ( EuroQol-5D questionnaire)

  1 year

Study Arms (1)

Performed electrosclerotherapy

All patients who performed electrosclerotherapy in the treatment of vascular malformations

Drug: Bleomycin

Interventions

Bleomycin DRUG

Using electroporation to infuse bleomycin in the lesion

Performed electrosclerotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by low-flow vascular malformations

You may qualify if:

• Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
• Non-indication for embolizing treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Vascular Malformations

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 3, 2024
• Study Start: October 28, 2023
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): November 28, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

IT (1)