| CTRI Number |
CTRI/2023/06/054329 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How safe & effective
is Endovenous Laser Ablation (EVLA) of lower limb varicose vein in Patients with both Superficial and Deep Venous Disease. |
|
Scientific Title of Study
|
The Safety & Efficacy of Endovenous Laser Ablation of Superficial Vein in Patients with Combined Superficial and Segmental Deep Venous Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushpinder Singh Khera |
| Designation |
Professor & Head of department |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of diagnostic & Interventional Radiology, All India Institute of Medical Sciences, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996914 |
| Fax |
|
| Email |
pushpinderkhera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pushpinder Singh Khera |
| Designation |
Professor & Head of department |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Diagnostic & Interventional Radiology, AIIMS, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996914 |
| Fax |
|
| Email |
pushpinderkhera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajjat Shaikh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Diagnostic & Interventional Radiology, AIIMS Jodhpur
Department of Diagnostic & Interventional Radiology, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08805126050 |
| Fax |
|
| Email |
dr.rajjat1707@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
AIIMS HOSPITAL, JODHPUR |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Pushpinder Singh Khera |
All India Institute of Medical Sciences |
Department of Diagnostic & Interventional Radiology, AIIMS hospital, Jodhpur.
Jodhpur
RAJASTHAN |
8003996914
pushpinderkhera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I83||Varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emdovenous laser Ablation (EVLA) of Superficial veins of lower limbs |
Duration of each EVLA procedure is around 1-2 hours.
Duration trial will be 18 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients with varicose veins with both superficial & deep venous reflux
patient with >70% recanalized chronic deep venous thrombosis with superficial reflux
patients with post-thrombotic varicose veins with superficial reflux will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient with acute DVT.
2. Pregnancy.
3. Patients on chronic hemodialysis.
4. Non-consenting patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| safety & efficacy of endovenous laser ablation of superficial veins in patients with combined superficial and segmental deep venous disease |
POST OPERATIVE DAY 1, 1 MONTH & 3 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of technical success, the incidence of recurrent DVT post procedure, other complications, and recurrence of varicose veins. |
POST OPERATIVE DAY 1, 1 MONTH & 3 MONTHS. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response (Others) - results & Conclusions of the Study
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.rajjat1707@gmail.com].
- For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Great saphenous vein (GSV) reflux is important in the development of signs and symptoms of chronic venous insufficiency. The combination of varicose veins and deep vein thrombosis (DVT) / deep venous insufficiency is a common clinical scenario. In the presence of combined superficial and deep vein reflux, it is always possible to treat superficial reflux.
This is a single-center, single-arm, prospective interventional study to evaluate the safety & efficacy of Endo-venous laser ablation of the superficial saphenous veins in patients combined with superficial & deep venous disease. The primary outcome measures will be the improvement in venous clinical severity score at 1 & 3 months & secondary outcome measures will be to evaluate the technical success rate & the incidence of recurrent DVT post-procedure, other complications, and recurrence of varicose veins at 1 & 3 months.
|