An interventional study of Bleomycin electrosclerotherapy treatment in Vascular Malformations, sponsored by South Tees Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by South Tees Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →South Tees Hospitals NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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)
Time frame: 8 weeks
Clinician assessment tool of treatment response
Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured
Time frame: 8 weeks
To collect documented side effects following electrosclerotherapy treatment.
To collect documented side effects following electrosclerotherapy treatment using diary
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Dec 2022, 24 months after the start.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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South Tees Hospitals NHS Foundation Trust