Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study (BEST)

South Tees Hospitals NHS Foundation Trust

Status: Enrolling

Conditions: Vascular Malformations

Treatments: Other: Bleomycin electrosclerotherapy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05494710

248206

Details and patient eligibility

About

The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations.

• Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels
• Electroporation = application of an electric field to vessels treated with a handheld needle electrode
• Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• New patients presenting with a vascular malformation suitable for Bleomycin sclerotherapy treatment
• Existing patients presenting with a poor response to treatment, performed more than 6 months ago
• Placement of a needle electrode into the vascular malformation is technically possible
• Evaluation of response to treatment is possible on photo documentation
• Patients agreeing to participate in the study
• The ability to understand written and spoken English

Exclusion criteria

• Patients not agreeing to participate in the study
• Pregnancy
• Breastfeeding
• Previous high systemic Bleomycin exposure (more than 3000 IU)
• Patients unable to provide written, informed consent
• Patients in which needle electrode placement is not possible
• Response to treatment not evaluable by photo documentation
• Patients unable to speak English

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Bleomycin electrosclerotherapy treatment

Experimental group

Description:

Bleomycin electrosclerotherapy treatment administered. The combination of Bleomycin and electroporation of the treated area is called electrochemotherapy (ECT).

Treatment:

Other: Bleomycin electrosclerotherapy treatment