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NCT02080013 Clinical Trial

Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Varicose Veins Clinical Trial

Official title:
Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02080013
Other study ID # JVS-D-14-00218
Secondary ID
Status Completed
Phase N/A
First received March 4, 2014
Last updated April 2, 2014
Start date December 2011
Est. completion date November 2013

Study information
Verified date March 2014
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ministry of Health
Study type Interventional

Clinical Trial Summary

our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.

Description:

Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible

Exclusion Criteria:

- Exclusion criteria consisted of:

- Current deep vein thrombosis (DVT)

- Thrombus in the vein of interest

- Previous GSV treatment

- Pregnancy

- Known malignancy

- Significant arterial disease (ankle : brachial pressure index below 0•8)

- Use of anticoagulant medication.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• radiofrequency
ClosureFAST

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 30 days Yes
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