Vascular MalformationsNCT07720570
Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations
An observational study of Vascular Malformations, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Vascular Malformations
- What is being tested?
- Bleomycin electrosclerotherapy (BEST)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Invasive treatment of the vascular malformation within 6 months before enrollment, including surgery, sclerotherapy, or laser treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Capital Region of Denmark, 2100
About this study
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.
Read more
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
- Being tested
- Bleomycin electrosclerotherapy (BEST)
- Keywords
- Bleomycin electrosclerotherapy, Electroporation, Sclerotherapy, Patient-reported outcome measures, Slow-flow vascular malformations, Vascular malformations
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin electrosclerotherapy (BEST)Procedure or surgery
Also called 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after BEST
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the day of the BEST procedure to the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Caroline Clausen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Caroline Clausen, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720570
- Sponsor's protocol ID
- p-2026-21479
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gehr J, Hindso L, Taudorf M, Eiberg JP, Frevert SC, Jensen RJ, Kaltoft M, Lonn LB, de la Motte LR, Strom M, Clausen C. Effectiveness and Safety of Bleomycin Electrosclerotherapy for Slow-Flow Vascular Malformations: A Systematic Review. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1105-1116. doi: 10.1007/s00270-026-04441-3. Epub 2026 Apr 27.
PubMed 42045624
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations
- ClinicalTrials.gov ID
- NCT07720570
- Acronym / sponsor ID
- p-2026-21479
- Conditions
- Vascular Malformations
- Keywords
- Bleomycin electrosclerotherapy, Electroporation, Sclerotherapy, Patient-reported outcome measures, Slow-flow vascular malformations, Vascular malformations
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Invasive treatment of the vascular malformation within 6 months before enrollment, including surgery, sclerotherapy, or laser treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bleomycin electrosclerotherapy (BEST)Also: BESTBleomycin electrosclerotherapy combines intralesional administration of bleomycin with local electroporation, which transiently increases cell membrane permeability and enhances intracellular drug uptake within the vascular malformation. | Procedure or surgery | – |
Primary outcome
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.
4 secondary outcomes
Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
Time frame: Baseline and 6 months after BEST
Pain intensity measured using a visual analogue scale (VAS)
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
Change from baseline in vascular malformation size assessed by MRI
Time frame: Baseline and 6 months after BEST
Number of participants with adverse events following BEST
Time frame: From the day of the BEST procedure to the 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 42045624Gehr J, Hindso L, Taudorf M, Eiberg JP, Frevert SC, Jensen RJ, Kaltoft M, Lonn LB, de la Motte LR, Strom M, Clausen C. Effectiveness and Safety of Bleomycin Electrosclerotherapy for Slow-Flow Vascular Malformations: A Systematic Review. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1105-1116. doi: 10.1007/s00270-026-04441-3. Epub 2026 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Clausen, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Malformations, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores (time frame: Baseline and 6 months after BEST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07720570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.