MedTrace Logo

Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations

NCT07720570 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Vascular Malformations

Interventions

PROCEDURE

Bleomycin electrosclerotherapy (BEST)

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.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Caroline Clausen, MD, PhD · Rigshospitalet, Denmark

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07720570 on ClinicalTrials.gov