Vascular MalformationsBESVAMNCT06189092
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
An observational study of Vascular Malformations, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vascular Malformations
- What is being tested?
- Bleomycin
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2023to 28 Nov 2027
- How long will I take part?
- 1 Year
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by low-flow vascular malformations
Who may be able to join
- Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
- Non-indication for embolizing treatment
- Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.
Who cannot join
- Previous treatment for < 30 days
- Pregnancy and lactation status
- Patients of childbearing age without contraceptive use
- Presence of metal synthetic media
- COPD with FiO2 < 30 mmHg
- Impaired renal function with eGFR<30 ml/min/1.73mq
Show all 10Show fewer
- Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
- Patients who have already received a cumulative dose of Bleomycin ≥100 mg
- Patients who have undergone prior thoracic radiotherapy
- Patients with a history of seizures and epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40136
Giancarlo Facchini, MD, +39 333 650 0944, giancarlo.facchini@ior.it
About this study
Official title: Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.
- Conditions
- Vascular Malformations
- Being tested
- Bleomycin
- Keywords
- Electrosclerotherapy
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleomycinDrug
Using electroporation to infuse bleomycin in the lesion
| Study group | Role | What they receive |
|---|---|---|
| Performed electrosclerotherapy | All patients who performed electrosclerotherapy in the treatment of vascular malformations Receives: Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction in cm
Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.
Measured: 1 year
Secondary outcomes (2)
Reduction of pain (VAS score)
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Measured: 1 year
Improvement in quality of life ( EuroQol-5D questionnaire)
Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0.
The minimum value represents the worst possible health condition. The maximum value of 1.0 represents the best possible health condition. A value of 1.0 indicates that the patient has no problem in any of the five dimensions assessed by the questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start28 Oct 2023
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- 65 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189092
- Sponsor's protocol ID
- CE AVEC: 639/2023/Oss/IOR
- Acronym
- BESVAM
- Status last verified
- May 2026
- First submitted
- 30 Nov 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
- ClinicalTrials.gov ID
- NCT06189092
- Acronym / sponsor ID
- BESVAM / CE AVEC: 639/2023/Oss/IOR
- Conditions
- Vascular Malformations
- Keywords
- Electrosclerotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 3 Jan 2024 (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.
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performed electrosclerotherapy | – | Drug: BleomycinAll patients who performed electrosclerotherapy in the treatment of vascular malformations |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by low-flow vascular malformations
Key inclusion criteria (3 listed)
- Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
- Non-indication for embolizing treatment
- Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.
Key exclusion criteria (10 listed)
- Previous treatment for < 30 days
- Pregnancy and lactation status
- Patients of childbearing age without contraceptive use
- Presence of metal synthetic media
- COPD with FiO2 < 30 mmHg
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 |
|---|---|---|
| BleomycinUsing electroporation to infuse bleomycin in the lesion | Drug | Performed electrosclerotherapy |
Primary outcome
Volume reduction in cm
Time frame: 1 year
Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.
2 secondary outcomes
Reduction of pain (VAS score)
Time frame: 1 year
Improvement in quality of life ( EuroQol-5D questionnaire)
Time frame: 1 year
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 May 2026.
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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.
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 Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 May 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume reduction in cm (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.