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CTRI Number  CTRI/2025/12/099973 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two minimally invasive ultrasound guided treatments - radiofrequency ablation and sclerotherapy for lesion size reduction in patients with venous malformations  
Scientific Title of Study   Comparative Efficacy of Ultrasound-Guided Radiofrequency Ablation versus Sclerotherapy for Venous Malformations: A Randomized Controlled Trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vineet Upadhyaya 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Radiodiagnosis and Interventional Radiology, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9819011725  
Fax    
Email  vrualt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amarinder Singh Malhi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Radiodiagnosis and Interventional Radiology, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9968745855  
Fax    
Email  drasmalhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vineet Upadhyaya 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Radiodiagnosis and Interventional Radiology, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9819011725  
Fax    
Email  vrualt@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Ansari Nagar, New Delhi, 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  AIIMS, Ansari Nagar, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Upadhyaya  AIIMS  Department of Radiodiagnosis and Interventional Radiology, AIIMS, Ansari Nagar, New Delhi, 110029
South
DELHI 
9819011725

vrualt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q279||Congenital malformation of peripheral vascular system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Radiofrequency Ablation  Patients with slow flow venous malformations of the extremities will be treated with Radiofrequency Ablation on a single day 
Comparator Agent  Sclerotherapy  Patients with slow flow venous malformations of the extremities will be treated with polidocanol foam sclerotherapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of 18 to 75 years of age with slow flow venous malformations of the extremities. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage reduction in lesion size   Percentage reduction in lesion size at 1 day, 1 week, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Post procedural complications  1 day, 1 week, 1 month, 3 months, 6 months 
Reduction of internal vascularity on colour Doppler  1 day, 1 week, 1 month, 3 months, 6 months 
Pain relief and functional improvement  1 day, 1 week, 1 month, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Venous malformations (VMs) are congenital, low-flow vascular anomalies that commonly present with pain, swelling, cosmetic concerns, and functional impairment. Sclerotherapy is the current standard minimally invasive treatment, but multiple sessions are often required and treatment response may be variable. Radiofrequency ablation (RFA) is an emerging image-guided thermal technique that may offer more effective lesion devascularization with fewer sessions.

This randomized, active-controlled, interventional trial aims to compare the efficacy and safety of ultrasound-guided RFA versus sclerotherapy in patients with slow-flow venous malformations. Eligible participants will be randomized into two parallel groups: one undergoing RFA and the other receiving standard sclerotherapy. The primary outcome is percentage reduction in VM volume on imaging at 6 months. Secondary outcomes include improvement in pain, symptom relief, and procedure-related complications.

The study is intended to generate comparative evidence to determine whether RFA provides superior or equivalent clinical outcomes to sclerotherapy in the management of slow-flow venous malformations, thereby guiding future therapeutic decision-making.

 
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