Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

NCT05494710 | Unknown

• 1 other identifier: 248206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Vascular Malformations

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To collect documented side effects following electrosclerotherapy treatment.

  2 years

Study Arms (1)

Bleomycin electrosclerotherapy treatment

EXPERIMENTAL

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

Other: Bleomycin electrosclerotherapy treatment

Interventions

Bleomycin electrosclerotherapy treatment OTHER

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

Bleomycin electrosclerotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead
• Teesside University: collaborator

Study Sites (1)

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vascular Malformations

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Clare Proctor

CONTACT

01642 854192; clareproctor1@nhs.net

Hyder Latif, BA (hons)

CONTACT

01642 854763; Hyder.latif3@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group of patients receiving same treatment

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: August 10, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

GB (1)