Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07720570

Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo BEST as part of routine clinical care
  • Diagnosis of a slow-flow vascular malformation confirmed by contrast-enhanced MRI performed within 6 months before enrollment.

Exclusion criteria

  • Invasive treatment of the vascular malformation within 6 months before enrollment, including surgery, sclerotherapy, or laser treatment.

Treatment and study plan

Bleomycin electrosclerotherapy (BEST)

Procedure

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.

Other names: BEST

Primary outcomes

  1. Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores

    Time frame: Baseline and 6 months after BEST

    The OVAMA questionnaire is a condition-specific patient-reported outcome measure assessing symptoms and appearance related to vascular malformations.

Secondary outcomes

  1. Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores

    Time frame: Baseline and 6 months after BEST

    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.

  2. Pain intensity measured using a visual analogue scale (VAS)

    Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST

    Participants rate pain intensity using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain). For participants aged 7 years or older.

  3. Change from baseline in vascular malformation size assessed by MRI

    Time frame: Baseline and 6 months after BEST

    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.

  4. Number of participants with adverse events following BEST

    Time frame: From the day of the BEST procedure to the 6-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.