Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

Last updated: August 9, 2022
Sponsor: South Tees Hospitals NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abnormal Blood Vessels (Arteriovenous Malformations)

Birth Defects

Holoprosencephaly

Treatment

N/A

Clinical Study ID

NCT05494710
248206
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New patients presenting with a vascular malformation suitable for Bleomycinsclerotherapy treatment
  • Existing patients presenting with a poor response to treatment, performed more than 6months 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

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

Total Participants: 20
Study Start date:
December 01, 2020
Estimated Completion Date:
December 01, 2022

Connect with a study center

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BW
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.