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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04526626
Other study ID # HKUSZH201901013
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date June 30, 2022

Study information

Verified date August 2020
Source The University of Hong Kong-Shenzhen Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis of long saphenous varicose veins

Exclusion Criteria:

- Contraindicated to operation due to severe comorbidities

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
Thermal injury to long saphenous vein

Locations

Country Name City State
China University of Hong Kong Shenzhen Hospital Shenzhen Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong-Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical success Occlusion of the long saphenous vein up to 24 months
Primary Complications Deep vein thrombosis, skin burn 2 weeks after operation
Primary Recurrence of varicose vein Recurrence of varicose vein up to 24 months
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