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Completed
NCT07728825
Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck
Conditions: Vascular Malformations, Venous Malformation, Lymphatic Malformation
Sex: All
Ages: 1 Year – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 20
Sponsor: University Of Anbar
Location: Al-Fallujah Teaching Hospital Fallujah Al-Anbar Governorate
Summary
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Eligibility Criteria
Inclusion Criteria:
* Age older than one year
* Clinically and radiologically confirmed low-flow vascular malformation of the head and neck
* No prior bleomycin therapy
* Medically fit for outpatient intervention
Exclusion Criteria:
* High-flow vascular malformation
* Pregnancy or lactation
* Documented hypersensitivity to bleomycin
* Pre-existing pulmonary or hepatic disease
* Bleeding disorder or current anticoagulant use
* Renal impairment (serum creatinine \> 1.5 mg/dL or estimated glomerular filtration rate \< 60 mL/min/1.73 m²)
* Active infection at or near the treatment site
Source: ClinicalTrials.gov (NCT07728825). StuddyBuddy aggregates publicly available trial information.