Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Primary Purpose
Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Sham Comparator
Arm Label
ClosureFast group
group 1
Arm Description
Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux
EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02080013
Brief Title
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Official Title
Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.
Detailed Description
Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ClosureFast group
Arm Type
Sham Comparator
Arm Description
Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux
Arm Title
group 1
Arm Type
Sham Comparator
Arm Description
EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Intervention Type
Other
Intervention Name(s)
radiofrequency
Other Intervention Name(s)
ClosureFAST
Intervention Description
ClosureFAST
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossam M. Saleh, PhD
Organizational Affiliation
Vascular Surgery Department, Ain Shams University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
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