| 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
|
|
|
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
|
|
|
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. |