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

Primary Purpose

Vascular Malformations

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bleomycin electrosclerotherapy treatment
Sponsored by
South Tees Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Malformations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Tees Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bleomycin electrosclerotherapy treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Clinician assessment tool of treatment response
Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured

Secondary Outcome Measures

To collect documented side effects following electrosclerotherapy treatment.
To collect documented side effects following electrosclerotherapy treatment using diary

Full Information

First Posted
January 26, 2022
Last Updated
August 9, 2022
Sponsor
South Tees Hospitals NHS Foundation Trust
Collaborators
Teesside University
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1. Study Identification

Unique Protocol Identification Number
NCT05494710
Brief Title
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
Acronym
BEST
Official Title
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Tees Hospitals NHS Foundation Trust
Collaborators
Teesside University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Malformations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group of patients receiving same treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bleomycin electrosclerotherapy treatment
Arm Type
Experimental
Arm Description
Bleomycin electrosclerotherapy treatment administered. The combination of Bleomycin and electroporation of the treated area is called electrochemotherapy (ECT).
Intervention Type
Other
Intervention Name(s)
Bleomycin electrosclerotherapy treatment
Intervention Description
The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).
Primary Outcome Measure Information:
Title
Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment
Description
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)
Time Frame
8 weeks
Title
Clinician assessment tool of treatment response
Description
Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To collect documented side effects following electrosclerotherapy treatment.
Description
To collect documented side effects following electrosclerotherapy treatment using diary
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Proctor
Phone
01642 854192
Email
clareproctor1@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hyder Latif, BA (hons)
Phone
01642 854763
Email
Hyder.latif3@nhs.net
Facility Information:
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

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