| CTRI Number |
CTRI/2024/06/068245 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining the effectiveness of Cyanoacrylate Glue in treating Recurrent Perforators following Primary Closure of Lower Limb Varicose Veins |
|
Scientific Title of Study
|
Efficacy of cyanoacrylate glue for recurrent
perforators after primary closure of lower limb varicose veins: A prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalit Nirwan |
| Designation |
Fellowship Student |
| Affiliation |
Datta Meghe Hospital Sawangi |
| Address |
Datta Meghe Hospital Cath lab Room Department of Interventional Radiology Datta Meghe Institute of Higher Education and Research Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422440440 |
| Fax |
|
| Email |
lalitnirwan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shishir Rawekar |
| Designation |
Asistant Professor |
| Affiliation |
Datta Meghe Hospital |
| Address |
Datta Meghe Hospital Cath lab Room Department of Interventional Radiology Datta Meghe Institute of Higher Education and Research Sawangi
MAHARASHTRA
442001
India |
| Phone |
9422440440 |
| Fax |
|
| Email |
shishir.rawekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalit Nirwan |
| Designation |
Fellowship Student |
| Affiliation |
Datta Meghe Hospital Sawangi |
| Address |
Cathlab Room
Department of Interventional Radiology
Datta Meghe Hospital
Datta Meghe Institute of Higher Education and Research
Sawangi, Wardha
Maharashtra
India
442001
Cathlab Room
Department of Interventional Radiology
Datta Meghe Hospital
Datta Meghe Institute of Higher Education and Research
Sawangi, Wardha
Maharashtra
India
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422440440 |
| Fax |
|
| Email |
lalitnirwan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cathlab Room
Department of Interventional Radiology
Datta Meghe Hospital
Datta Meghe Institute of Higher Education and Research
Sawangi, Wardha
Maharashtra
India
442001 |
|
|
Primary Sponsor
|
| Name |
Dr Lalit Nirwan |
| Address |
Cathlab Room
Department of Interventional Radiology
Datta Meghe Hospital
Datta Meghe Institute of Higher Education and Research
Sawangi, Wardha
Maharashtra
India
442001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Lalit Nirwan |
Datta Meghe Hospital Swangi |
Datta Meghe Hospital Cath lab Room Department of Interventional Radiology Datta Meghe Institute of Higher Education and Research Sawangi
Wardha
MAHARASHTRA |
9422440440
lalitnirwan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research DU Sawangi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I838||Varicose veins of lower extremities with other complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N butyl cyanoacrylate |
N butyl cyanoacrylate is a liquid embolic agent used percutaneously to occlude varicose vein perforators.
Dose- N butyl cyanoacrylate glue small volume (0.1 to 0.3 mL) shall be injected in a perforator using insulin syringe.
Route- Percutaneously in a perforator under ultrasound guidance and aspectic precaution.
Frequency and Duration- Procedure will be performed once for recurrent perforator.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of lower limb varicose veins previously treated with any modality.
Patient who have recurrent perforator identified on Ultrasound.
Patient willing to sign informed consent and participate in study. |
|
| ExclusionCriteria |
| Details |
Patients with Deep venous thrombosis.
Pregnant and lactating women.
Undiagnosed cause of recurrence of varicose veins.
Any patient with terminal illness such as cancer.
Any other condition that in the view of Principal Investigator demands exclusion from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of closure rates of recurrent perforators
Improvements in symptoms
Complications
|
6 wks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome
Improvement in Symptoms To evaluate the improvement in symptoms associated with varicose veins due to recurrent perforator following closure using cyanoacrylate glue at 6 wks
Recurrence rate To assess the rate of perforator recurrence post cyanoacrylate glue closure in cases with recurrent perforators treated with glue at 6 wks
Adverse Events To document & evaluate any adverse events associated with cyanoacrylate glue closure |
6 wks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
01/09/2024 |
| Date of First Enrollment (Global) |
10/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study titled Cyanoacrylate Glue for Recurrent Perforators After Primary Closure of Lower Limb Varicose Veins: A Prospective Study aimed to evaluate the effectiveness and safety of using cyanoacrylate glue for the treatment of recurrent perforators causing following primary closure of varicose veins. Background Chronic venous insufficiency of the lower limb is a common condition that affects a significant portion of the population. The most prevalent form of this disease is due to great saphenous vein GSV and perforator valvular incompetence, leading to symptoms ranging from fatigue and swelling to more severe complications like ulceration. Recurrent perforators post primary closure causes recurrent varicose vein and symptoms. Purpose The trial will be conducted to explore the technical feasibility, efficiency, and safety of cyanoacrylate embolization using n butyl cyanoacrylate glue. The study sought to determine if this method could be an effective outpatient procedure for treating recurrent perforators following primary closure of varicose veins. |