Back to resultsEndovenous RFA Versus Ligation and Striping for Varicose Veins
Primary Purpose
Varicose Veins of Lower Limb
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Radiofrequency ablation, High ligation and striping
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of long saphenous varicose veins
Exclusion Criteria:
- Contraindicated to operation due to severe comorbidities
Sites / Locations
- University of Hong Kong Shenzhen Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High ligation and stripping
Arm Description
High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins
Outcomes
Primary Outcome Measures
Technical success
Occlusion of the long saphenous vein
Complications
Deep vein thrombosis, skin burn
Recurrence of varicose vein
Recurrence of varicose vein
Secondary Outcome Measures
Full Information
NCT ID
NCT04526626
First Posted
March 25, 2020
Last Updated
August 25, 2020
Sponsor
The University of Hong Kong-Shenzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04526626
Brief Title
Endovenous RFA Versus Ligation and Striping for Varicose Veins
Official Title
Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong-Shenzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb
Keywords
Radiofrequency ablation, High ligation and striping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High ligation and stripping
Arm Type
Experimental
Arm Description
High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
Other Intervention Name(s)
ClosureFast, Medtronic
Intervention Description
Thermal injury to long saphenous vein
Primary Outcome Measure Information:
Title
Technical success
Description
Occlusion of the long saphenous vein
Time Frame
up to 24 months
Title
Complications
Description
Deep vein thrombosis, skin burn
Time Frame
2 weeks after operation
Title
Recurrence of varicose vein
Description
Recurrence of varicose vein
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of long saphenous varicose veins
Exclusion Criteria:
Contraindicated to operation due to severe comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailei Li, M.D, Ph.D
Organizational Affiliation
University of Hong Kong Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endovenous RFA Versus Ligation and Striping for Varicose Veins
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