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

August 9, 2022 updated by: South Tees Hospitals NHS Foundation Trust

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

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
Time Frame: 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)
8 weeks
Clinician assessment tool of treatment response
Time Frame: 8 weeks
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.
Time Frame: 2 years
To collect documented side effects following electrosclerotherapy treatment using diary
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Tees Hospitals NHS Foundation Trust

Collaborators

Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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