An observational study in Vascular Malformations, sponsored by Rigshospitalet, Denmark. Enrolling by invitation at 1 site in Denmark. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Rigshospitalet, Denmark · Observational
Slow-flow vascular malformations consist of abnormally formed veins, capillaries, lymphatic vessels, or a combination of these. They can cause pain, swelling, functional limitations, and concerns about appearance and may substantially affect quality of life. Bleomycin electrosclerotherapy (BEST) is an emerging treatment in which the sclerosant bleomycin is injected into the malformation and brief electrical pulses are applied to increase its local effect.
As treatment of slow-flow vascular malformations primarily aims to alleviate symptoms and improve quality of life, patient-reported outcomes are central to assessing treatment benefit. However, the available evidence on patient-reported outcomes following BEST is sparse and heterogeneous, and prospective data are particularly limited.
This prospective observational study follows children and adults undergoing BEST as part of routine clinical care at Copenhagen University Hospital - Rigshospitalet.
The OVAMA questionnaire will be used to assess symptoms and appearance in all participants before treatment and at the 6-month follow-up. Depending on age, additional patient-reported measures will assess health-related quality of life (PROMIS-29) and pain (VAS) during follow-up. For adults, the study will assess changes in lesion size by comparing magnetic resonance imaging (MRI) scans performed before treatment and at 6 months. Adverse events will be recorded throughout follow-up.
The study aims to evaluate whether patient-reported outcomes improve during the 6 months after BEST and to provide further information about treatment safety.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 27 observational studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Potential participants are identified among children and adults with slow-flow vascular malformations assessed by the multidisciplinary vascular malformation team at Copenhagen University Hospital - Rigshospitalet.
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Bleomycin electrosclerotherapy combines intralesional administration of bleomycin with local electroporation, which transiently increases cell membrane permeability and enhances intracellular drug uptake within the vascular malformation.
Also known as: BEST
Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores
The OVAMA questionnaire is a condition-specific patient-reported outcome measure assessing symptoms and appearance related to vascular malformations.
Time frame: Baseline and 6 months after BEST
Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
The Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) is a generic patient-reported outcome measure assessing physical, mental, and social health. For participants aged 18 years or older.
Time frame: Baseline and 6 months after BEST
Pain intensity measured using a visual analogue scale (VAS)
Participants rate pain intensity using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain). For participants aged 7 years or older.
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
Change from baseline in vascular malformation size assessed by MRI
MRI will be used to compare the size of the treated vascular malformation before BEST and 6 months after treatment. For participants aged 18 years or older.
Time frame: Baseline and 6 months after BEST
Number of participants with adverse events following BEST
Adverse events occurring on the day of BEST or during follow-up will be recorded, including their nature, severity, management, and outcome. Events will be classified according to the CIRSE and Clavien-Dindo classification systems.
Time frame: From the day of the BEST procedure to the 6-month follow-up
Plan to share: No
Start is estimated for Aug 2026; primary completion for Sep 2027, 13 months later.
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