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

• Sponsor: South Tees Hospitals NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05494710
• Collaborator: Teesside University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Malformations	Other: Bleomycin electrosclerotherapy treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single group of patients receiving same treatmentsingle group of patients receiving same treatment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment [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)

2. Clinician assessment tool of treatment response [8 weeks]

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

Secondary Outcome Measures

1. To collect documented side effects following electrosclerotherapy treatment. [2 years]

   To collect documented side effects following electrosclerotherapy treatment using diary

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Tees Hospitals NHS Foundation Trust	Middlesbrough		United Kingdom	TS4 3BW

Sponsors and Collaborators

• South Tees Hospitals NHS Foundation Trust
• Teesside University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: South Tees Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT05494710
• Other Study ID Numbers: 248206
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vascular Malformations; Congenital Abnormalities; Bleomycin

Study Results

No Results Posted as of Aug 10, 2022