Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Vascular Malformations Clinical Trial

— BEST  

Official title:

Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494710
• Other study ID #: 248206
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: South Tees Hospitals NHS Foundation Trust
• Contact: Clare Proctor
• Phone: 01642 854192
• Email: clareproctor1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Malformations

Intervention

Other:
• Bleomycin electrosclerotherapy treatment
The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).

Locations

Country	Name	City	State
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough

Sponsors (2)

Lead Sponsor	Collaborator
South Tees Hospitals NHS Foundation Trust	Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To collect documented side effects following electrosclerotherapy treatment.	To collect documented side effects following electrosclerotherapy treatment using diary	2 years