Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
NCT ID: NCT05494710
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-12-01
2022-12-01
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bleomycin electrosclerotherapy treatment
Bleomycin electrosclerotherapy treatment administered. The combination of Bleomycin and electroporation of the treated area is called electrochemotherapy (ECT).
Bleomycin electrosclerotherapy treatment
The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).
Interventions
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Bleomycin electrosclerotherapy treatment
The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Teesside University
OTHER
South Tees Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Locations
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South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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248206
Identifier Type: -
Identifier Source: org_study_id
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