Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Conditions
-----------------
Vascular Malformations

Intervention / Treatment
-----------------
* Other: Bleomycin electrosclerotherapy treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group of patients receiving same treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bleomycin electrosclerotherapy treatment<br>Bleomycin electrosclerotherapy treatment administered. The combination of Bleomycin and electroporation of the treated area is called electrochemotherapy (ECT). | Other: Bleomycin electrosclerotherapy treatment<br>* The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment | Patient reported quality of life after a single electrosclerotherapy treatment of vascular malformations - change in scores measured using Birthmark Quality of Life questionnaire (8 items measured on 5 point scale) | 8 weeks | 
| Clinician assessment tool of treatment response | Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect documented side effects following electrosclerotherapy treatment. | To collect documented side effects following electrosclerotherapy treatment using diary | 2 years |