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A study comparing two minimally invasive ultrasound guided treatments - radiofrequency ablation and sclerotherapy for lesion size reduction in patients with venous malformations

Comparative Efficacy of Ultrasound-Guided Radiofrequency Ablation versus Sclerotherapy for Venous Malformations: A Randomized Controlled Trial - NILL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099973
Enrollment
40
Registered
2025-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: Q279- Congenital malformation of peripheral vascular system, unspecified

Interventions

Intervention1: Radiofrequency Ablation: Patients with slow flow venous malformations of the extremities will be treated with Radiofrequency Ablation on a single day Control Intervention1: Sclerotherap

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 18 to 75 years of age with slow flow venous malformations of the extremities.

Exclusion criteria

Exclusion criteria: Patients less than 18 years of age. High flow arteriovenous malformations Diffuse or multicompartmental lesions larger than 6 cm in maximum dimension Presence of coagulopathy, local infection, or ulceration at the lesion site Pregnancy or lactation Severe systemic illness or contraindication to either procedure Unwillingness or inability to provide consent or complete scheduled follow up assessments

Design outcomes

Primary

MeasureTime frame
Percentage reduction in lesion sizeTimepoint: Percentage reduction in lesion size at 1 day, 1 week, 1 month, 3 months, 6 months

Secondary

MeasureTime frame
Post procedural complicationsTimepoint: 1 day, 1 week, 1 month, 3 months, 6 months;Reduction of internal vascularity on colour DopplerTimepoint: 1 day, 1 week, 1 month, 3 months, 6 months;Pain relief and functional improvementTimepoint: 1 day, 1 week, 1 month, 3 months, 6 months

Countries

India

Contacts

Public ContactDr Vineet Upadhyaya

All India Institute of Medical Sciences

drasmalhi@gmail.com9968745855

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026