Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Not Applicable

• Conditions: Vascular Malformations
• Interventions: Other: Bleomycin electrosclerotherapy treatment

• Registration Number: NCT05494710
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-01-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment	8 weeks	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)
Clinician assessment tool of treatment response	8 weeks	Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured

Secondary Outcome Measures

Name	Time	Method
To collect documented side effects following electrosclerotherapy treatment.	2 years	To collect documented side effects following electrosclerotherapy treatment using diary

Trial Locations

Locations (1)

South Tees Hospitals NHS Foundation Trust; 🇬🇧 Middlesbrough, United Kingdom