Treatment of low-flow vascular malformations with bleomycin electrosclerotherapy (BEST)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524123-45-00

Enrollment

140

Registered

2026-04-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VASCULAR MALFORMATION

Brief summary

To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.

Detailed description

Assessment of the effectiveness of BEST 12 months after the treatment., Feasibility of recruitment and treatment according to the Current Operating Procedures, Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0, Quality of life: QoL assessment with clinically validated OVAMA questioner.

Interventions

DRUGBleomycin medac

DRUG15 000 RÜ süstelahuse pulber

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.	—

Secondary

Measure	Time frame
Assessment of the effectiveness of BEST 12 months after the treatment., Feasibility of recruitment and treatment according to the Current Operating Procedures, Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0, Quality of life: QoL assessment with clinically validated OVAMA questioner.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 8, 2026