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
About this trial
This is an interventional treatment trial for Vascular Malformations
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
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
NCT ID
NCT05494710
First Posted
January 26, 2022
Last Updated
August 9, 2022
Sponsor
South Tees Hospitals NHS Foundation Trust
Collaborators
Teesside University
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
Learn more about this trial
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
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